TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Sr. Quality Engineer – Sustained Manufacturing to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Sustained Manufacturing of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams.  This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Faced paced work environment.

Essential Functions

• Initiate and/or consult in the development and/or update of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams.
• Provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
• Ensure the continuous efficiency and improvement of Test/Inspection Methods
• Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPAs, Complaints and NCRs.
• Provide statistical data / trending analysis on Complaints, NCRs and other quality metrics to drive escalation and appropriate Corrective Actions to mitigate future recurrences of nonconformances.
• Conduct audits for internal manufacturing processes to ensure compliance with work instructions, summarize findings, outline opportunities for improvement, and proactively identify potential non-conformances.
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Provide support for the compliance of Quality System support elements (QM 'feeder' systems) for the site QMS and the tracking & reporting of associated metrics as required.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Support site customer-requested auditing activities (Customer and Regulatory Agencies).
• Ensure compliance of all site personnel to site-level QMS and functional training requirements.
• Be able to read and understand blueprints.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 7+ years’ experience in a regulated manufacturing environment.
• Able to independently drive all items outlined in Essential Functions.

Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
• Ability to independently drive all items in Essential Functions.
• Lead and mentor new employees.

Preferred Skills

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation, a leader in the manufacturing of devices and components for major medical device companies, is looking for a motivated Senior Accounting Specialist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to the Controller, this position will have primary responsibilities for processing accounts payable and monthly accounting close activities. This position also assists the accounting department and covers the reception duties as needed.

Essential Functions

• Process accounts payable invoices through ARM System and process payments.
• Create and maintain paperless functionality and 3-way match principle utilizing the ARM System.
• Record and reconcile the Corporate American Express account and assist with travel arrangements as needed.
• Reconcile the aging and goods received not invoiced registers to the general ledger and resolve issues.
• Research and respond to queries from suppliers.
• Produce Positive Pay file for bank fraud monitoring services.
• Investigate A/P discrepancies and bring items to resolution.
• Provide back-up duties to front office reception as needed.
• Cross-train on other accounting functions as needed.
• Audit payroll file for accuracy and compliance. Payroll processing back-up.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in accounting or finance preferred.
• Minimum of 5 years' experience, preferably in a manufacturing company.
• Strong knowledge of ERP systems and Excel software. Epicor preferred.
• Able to work in a paperless environment.
• Prior experience using payroll software, preferably ADP.
• Possess a high attention to detail.
• Exhibit good time management skills and ability to prioritize workload.
• Motivated self-starter with ability to work both independently and as part of a team.
• Strong verbal and written English language communication skills.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Director of Finance to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

The Director of Finance has the responsibility for directing all aspects of accounting operations, overseeing all transactions related to the general ledger, receivables, payables, payroll, and financial reporting.

Essential Functions

• Manages all financial control and accounting activities including general accounting, payables/receivables and payroll.
• Responsible for analyzing the company's financial results with respect to profits, trends, costs, and compliance with budgets. Issues regular status and ad hoc reports to senior management.
• Provides strategic guidance around capital financing options to support company growth needs.
• Monitors operation results against operating plans and directs the preparation of financial, production output, and other reports used to measure and control plant activities and costs.
• Leads the financial and capital budgeting process.
• Recommends and implements programs to improve productivity, increase efficiencies, and reduce costs.
• Coordinates and develops all relationships with lending/financial institutions.
• Develops and maintains all necessary accounting policies and systems, including general ledger and financial reporting. Ensures that records are maintained in accordance with generally accepted accounting principles.
• Assists Senior Management in financial planning and results management. Works with other team members to understand revenue and cost drivers and define appropriate reports for tracking.
• Coordinating, preparing, and reviewing monthly, quarterly, and annual financial reports.
• Coordinating and/or preparing tax schedules, returns and information.
• Managing relationships with insurance providers and ensuring compliance.
• Managing all tax planning and compliance with all required federal, state, local, payroll, property, and other applicable taxes.
• Manages cash flow.
• Ensures financial control processes and systems comply with company policies, applicable regulations, and provide required information.
• Other Finance and Administrative duties as required.

Qualifications:

Education/Experience

• Bachelor's in business, finance or accounting. Masters preferred.
• Minimum of 10 years’ experience in a Senior Management role ideally with both external audit and in-house financial management experience gained in a high-growth organization.
• Experience in contract manufacturing.

Qualifications

• Entrepreneurial team player who can multitask.
• Superior management skills and the ability to influence and engage direct and indirect reports and peers.
• Self-reliant, good problem solver and results oriented.
• Energetic, flexible, collaborative, and proactive; a team leader who can positively and productively impact both strategic and tactical finance and administration initiatives.
• Exceptional written, oral, interpersonal, and presentation skills.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Application Engineer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will support the organization’s Turning, Milling and Grinding operations of complex medical devices through new development projects as well as optimization of existing legacy programs. Work in cross functional teams to drive continuous improvement and ensure production objectives are met; including but not limited to programming for new product development, optimization of legacy programs for improved throughput, standardization of programs to current best practices, and research and implementation of new tooling and process technology.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
• Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities.
• Actively participate in process development projects and DFM with internal and external teams
• Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates.
• Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
• Design fixtures for post processing operations.

Qualifications:

Education

• Associate degree in technical or scientific field or equivalent work experience.

Experience

• Minimum of 5 years’ experience of programming and machine set-up in a medical device manufacturing environment or similar.
• Strong knowledge of NC Code, Tooling, and Manufacturing Process
• Knowledge of CAD/CAM (SolidWorks and Esprit preferred)
• Blueprint reading and knowledge of Geometric Dimensioning and Tolerancing (GD&T)
• Effective communication to all levels of internal and external customers
• Ability to apply logic and reasoning to solve complex problems.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Summary of Position

Reporting to the Facilities Manager, this position will have direct responsibility for the overall cleanliness of all common “High Contact” areas of the facility, and the front office. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the highest level of cleanliness and safety possible in support of our mission to foster a desirable work environment for all employees and guests to our facility.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Daily routine cleaning of all common “High Contact” areas of the facility. Ex. include Cafeteria, hallways, door knobs and pulls, bathrooms and locker room area, and the front office.
• Routine vacuuming of carpeted areas and door mats.
• Occasional cleaning of windows, office dividers, and other glass per schedule and as needed.
• Light cleaning and trash removal of office areas.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience.

Experience

• Prior cleaning job experience preferred, but not required. Must have reliable transportation.

Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Ability to use basic hand-held tools to support maintenance activities.
• Strong verbal communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving furniture, rugs, etc. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Train and perform inspections on machined components, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers, and gages.
• Train and perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques.
• Demonstrate team leadership, train, and provide guidance to Quality Control personnel.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Provide basic programming assistance for complex inspection/test methods, as required.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
• Support physical and/or electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Support other Quality Department functions, as needed.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 7 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Knowledge of dimensional, visual, and mechanical inspection processes.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator I to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the processing of parts through various automated functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, prepare materials to be processed through various operations, and perform basic visual inspections on completed components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Prepare components to be processed through various automated metal finishing operations. Ex. include loading and un-loading of automated sand blasting or tumbling equipment, racking and un-racking components to support the anodize and passivation line.
• Perform visual inspections on completed components, as required.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Ability to use basic hand-held tools to support preventive maintenance activities.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

5:30pm-4 am - 15% differential
50 hours

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for an Operator II to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will have direct responsibility for the processing of parts through various functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, prepare materials to be processed through various operations, and perform basic visual and dimensional inspections on completed components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Prepare and process components through various metal finishing operations. Ex. include operation of manual sand blasting equipment, fixturing and operation of laser marking equipment, fixturing and operation of laser welding equipment, loading and un-loading heat treat-furnace, etc.
• Perform visual and basic dimensional inspections on completed components, as required using micrometers, calipers, microscope, etc.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical metal finishing equipment and processes.
• Ability to use basic hand-held tools to perform preventive maintenance activities.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.
• Strong verbal and written English language communication skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 50 pounds while moving components or fixtures/racking. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

6 am- 4:30 pm, 5:30 pm - 4 am
50 hours

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Inspector to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components by utilizing conventional layout inspection techniques and equipment.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Perform inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
• Support physical and/or electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Knowledge of dimensional, visual and mechanical inspection processes.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 20 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Quality Plans for Quality Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectiveness.
• Additional responsibilities as outlined in the full job description.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 4+ years of experience in a regulated manufacturing environment.

***Additional qualifications as outlined in the full job description.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a self- starter and highly motivated Post- Machining Operations Supervisor to join our organization. Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

The position is responsible for leading a team with a focus on maintaining the highest level of operational performance and quality possible within various manual and mechanical metal finishing and chemical finishing operations, Heat Treating, Deburring, Laser Welding, Assembly and Laser Marking of finished good devices and instruments, at TOMZ. This position is responsible to define and build the team; to ensure that the proper tools and training are in place for the team; and to coach and provide oversight to ensure the success of the team.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Define Department Structure and Build a Team geared toward success.
  • Ensure that staffing and resource levels are aligned with the needs of the department and that resources are deployed strategically to best utilize their capabilities.
  • Ensure that members of the department are properly trained and are equipped to be successful in meeting or exceeding the expectations of their given role.
  • Ensure that department schedules are aligned to consistently achieve the required level of output.
  • Ensure that equipment is maintained per preventive maintenance schedules and coordinate outside service or support as required to keep equipment in good repair.
• Coach, Mentor and Manage members of the department.
  • Monitor and maintain the performance records and document development plans through the performance review process for employees within the department.
  • Engage all members of the department and encourage a strategic, collaborative, problem solving environment focused on continuous improvement and driving new best practices.
  • Ensure adherence to company policy and expectations regarding start and end times for the shift and defined break times, and compliance to all Quality requirements.
  • Maintain attendance records and manage requests for time off within the department.
  • Monitor and maintain the Labor entries, review process standards.
• New Technology Integration    
  • Identify areas or operations within the department that create unsafe conditions through normal work processing, or with highly repetitive motion and collaborate with Engineering to develop and implement strategic automation solutions.
  • Collaborate with Engineering to introduce new technology and develop new best practices focused on providing device components with the highest level of quality; improving cycle times; and creating the most reliable and capable process possible.  
• Prioritize Workflow per the Master Schedule. Measure and Maintain Department Performance objectives such as on time delivery (schedule adherence), Production Efficiency, Scrap Rate, and Training Matrix Completion or other as deemed appropriate by senior management.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering discipline preferred).
• Lean Six Sigma Green Belt Certification Preferred or other continuous Improvement Lean Training preferred.

Experience

• Minimum of 5 years of experience in a manufacturing or engineering role showing career advancement with increased responsibly, in a regulated manufacturing environment.
• Minimum of 3 years of supervisory/coaching experience.
• Experience working in a Lean Manufacturing Environment.

Qualifications

• Ability to read and understand and Train/Coach general finishing operations per company procedures, work instructions, and best practices.
• Medical Device or other regulated manufacturing experience (Aerospace, Defense, Pharma., etc.)

Preferred Skills

• Knowledge of, and experience with, cGMP/ISO Standards.
• Strong verbal and written English language communication skills.
• Demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is frequently required to stand, and/or walk.  The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages.  The employee will be working with and around and directing others on the safe handling of hazardous chemicals that may require use of personal protective equipment (supplied by TOMZ). The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation is looking for highly skilled Application Engineer with a specific expertise in milling to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.

Summary of Position

Support the organization’s Turning, Milling and Grinding operations of complex medical devices through new development projects as well as optimization of existing legacy programs. Work in cross functional teams to drive continuous improvement and ensure production objectives are met; including but not limited to programming for new product development, optimization of legacy programs for improved throughput, standardization of programs to current best practices, and research and implementation of new tooling and process technology. TOMZ is a fast-paced work environment.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Ability to program various pieces of CNC equipment across multiple sites as directed to support critical and/or high-value projects milling, turning, and grinding, Multi spindle, Multi Axis and Swiss style programs for manufacture of medical devices- implants and instruments.
• Analyze drawings, design models, and sketches to determine dimensions and configuration of cuts, selection of cutting tools, machine speeds, and feed rates according to shop processes, customer specifications, and machine capabilities.
• Actively participate in process development projects and DFM with internal and external teams
• Revise programs to eliminate instruction errors, omissions, and update programs with new technology/methods to improve efficiency; meet customer delivery dates.
• Coordinate with Quality Engineering to help facilitate the development of Process Control Plans, Manufacturing Inspection Plans, and gaging/fixturing requirements.
• Machine set-up skills required to accomplish 1st article parts and short run NPI products. With an occasional small production run if needed.
• Design fixtures for post processing operations.
• Strong knowledge of NC Code, Tooling, and Manufacturing Process
• Knowledge of CAD/CAM software (SolidWorks and Esprit preferred)
• Blueprint reading and knowledge of Geometric Dimensioning and Tolerancing (GD&T)
• Effective communication to all levels of internal and external customers
• Ability to apply logic and reasoning to solve complex problems.

Qualifications:

Education

• Associate degree in technical or scientific field or equivalent work experience.

Experience

• Minimum of 5 years’ experience of programming and machine set-up in a medical device manufacturing environment or similar.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation is looking for a Quality Control Manager to join our organization. Founded in 1988, TOMZ is family owned and operated, and has become a top leader in manufacturing of devices and components for major medical device companies. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position is responsible for improving safety, quality, delivery, productivity and cost by proactively improving the quality systems of the company. The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback that promotes and strengthens relationships within the organization and customer satisfaction.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Plans, directs, monitors, maintain, support and coordinate all of the activities in the Quality department.
• Manage flow of jobs going through the Quality department and coordinate scheduling priorities, and the need for inspection personnel.
• Controls the duties and performance of inspectors by providing training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment- i.e: include microscopes, calipers, micrometers, and gages.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
• Approve or reject parts, components, assembly processes and finish products based on compliance and quality benchmarks.
• Collaborate with team members to achieve company, business unit and team goals.
• Maintain appropriate staffing levels to include hiring, training and employee performance.
• Proactively identify areas for improvement and implement plans to achieve and realize those improvements.
• Support physical and/or electronic record retention. Supervise use and maintenance of inspection equipment.
• Provide interpretation and manage external, internal, customer and supplier quality issues.
• Review, create, approve, and implement customer quality requirements including new projects, revision, or specification changes.
• Review and approve subcontractors’ quality documentation.
• Cooperate with department managers and customers.
• Participate and collaborate in company and quality meetings.

Qualifications:

Education

• Bachelor of Science in Engineering or another related field preferred or 5 years of directly transferrable work equivalency.
• ASQ-CQT certification preferred.

Experience

• 7+ years’ experience in a supervisorial/leadership role.
• 5+ years of Metrology experience

Additional Qualifications

• Knowledge of GD&T and ISO13485 regulations.
• Ability to automatically pivot in a fast-paced work environment.

Preferred Skills

• Microsoft Office, Visio, and Minitab are preferred.
• Strong communication and interpersonal skills.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is frequently required to stand, and/or walk.  The employee must occasionally lift and/or move up to 25 pounds while moving tooling, fixtures, equipment and/or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

6-4:30 pm

50

TOMZ Corporation is looking for a motivated Production Planner to join our organization! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

The Production Planner is responsible for assisting the Master Scheduler and the Supply Chain team to consistently meet customer expectations for delivery and service by effectively utilizing available shop capacity and resources and maintaining a balanced flow of material throughout the facility. This position may be located near any of our locations, Berlin, CT, Knightstown, IN or Big Lake, MN. This position is hybrid.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Responsible for loading and balancing the production schedule across multiple work-center groups and departments.
• Set clear, achievable delivery commitments for internal and external customers.
• Track planned work orders and adjust schedule to account for any production issues that directly impact the timing of completion.
• Analyze resource capacity and efficiently load each production machine and work center to maintain consistent flow of product throughout the facility.
• Support the S&OP process by continuous review of production performance and adherence to the master schedule, inventory status and capacity utilization.
• Maintain finished goods inventory at target levels to ensure high service levels for Vendor Managed Inventory (VMI). Monitor and adjust WIP and Finished Goods inventory levels on an ongoing basis to meet inventory turn goals.
• Collaborate with the Manufacturing Managers and the Master Scheduler to meet plant performance goals and objectives.
• Report key metrics as requested by senior management.

Qualifications:

Education

• BS/BA in Supply Chain, Business (desired) or equivalent combination of education and planning experience.

Experience

• 2-3 years of experience in a production planning role working for a direct manufacturer (required)

Qualifications

• 1-year experience planning in a machining environment, preferably in an ISO 13485 certified facility.
• ERP / MRP experience in Epicor or similar ERP software.
• Proficient with MS Office suite – advanced skills with MS Excel.
• APICS certification (CPIM or CSCP) preferred.

Preferred Skills

• Business Administration, Supply Chain, Logistics, Operations knowledge.
• Strong sense of urgency & attention to detail.
• Ability to take constructive guidance on planning preferences.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

TOMZ Corporation is looking for a Quality Engineering Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the Leadership and management of site-level Quality Engineering personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System.

Essential Functions

• This position may have direct-reporting responsibilities for daily activities of Quality personnel.
• Designated Site-level Management Representative for assurance of compliance to the TOMZ Quality Management System.
• Drive and support QMS initiatives and continuous improvement activities.
• Support establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
• Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality Engineering, as well as cross-functional teams.
• Work closely with Engineering and Operations teams to identify and drive actions that reduce the Cost of Poor Quality.
• Drive integration of new manufacturing capabilities, new test methods and innovation in technology, cost/labor reduction opportunities, product transfers, design transfers and sustained manufacturing customers.
• Provide Leadership and Guidance for Quality functions including, Product and Process Risk Management, Test Method Selection and Development, Control Point establishment, Risk and Severity-based Sampling Plan, Process Validation Strategy, Complaint Handling/Returns, Corrective/Preventive Actions, and Nonconforming Material Handling.
• Provide oversight and ensure compliance of Quality System support elements for the site QMS: Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; trending of associated metrics to drive continuous improvement initiatives.
• Provide Leadership and Guidance for Development Engineering, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
• Provide Leadership and Guidance for Risk Management (Process FMEAs), Limit Characterization, Inspection Controls, Technical Root Cause Investigation, and resulting Corrective Actions.
• Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees, and performed in compliance with Federal and local laws, as well as TOMZ policies.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 7 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
• Minimum of 5 years of experience in a regulated manufacturing environment.

Qualifications

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards:  ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Preferred Skills

• Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.