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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.