Join Us on Our Mission to Improve Patients' Lives.

TOMZ Corporation is looking to hire a Sr. Quality Engineer – Sustained Manufacturing 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

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. Fast-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 is looking to hire a highly motivated and driven Senior Process Quality Engineer 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

This position will be responsible for improving safety, quality, delivery, productivity and cost by proactively improving the processes of the company to reduce variation prevent nonconformities and drive Quality to the Source. The Process Quality Engineer will work to reduce the Cost of Poor Quality through sound scientific principles to lead the transition from Quality Control to Quality Assurance. This includes but is not limited to Process Analytical Technology (PAT), Precontrol, SPC, Human Factors Engineering, Process Validation, User Validation, Certified Operator Programs, Standard Work, Advance Metrology, Poka-Yoke, Jidoka, as well as using statistical techniques for identifying problems and resolving them using CAPA, Six Sigma and the Toyota Kata PDCA approach.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans to support New Product Introduction.
• 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.
• Collaborate with team members to achieve company, business unit and team goals.
• Proactively identify areas for improvement and implement plans to achieve and realize those improvements.
• Provide interpretation and manage external, internal, customer and supplier quality issues.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Authors Inspection Plans and defines process controls. 
• Defines Test Method.   
  • Subject  Matter  expertise  of  precision  measuring  instruments  and  their  application,  including but not limited to, calipers, micrometers, depth gages, indicators, and plug and  thread Go/No Go gages. 
• Execution and evaluation of Test Method Validations. 
• Creation of production visual standards and standardized acceptance criteria for TOMZ's manufacturing processes.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements. 
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required   
• Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans. 
• Support Gage calibration review, management, execution and evaluation. 
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts. 
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, resolving quality issues through the CAPA process. 
• Defines and Measures key process indicators. 
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families. 
• Generate ECOs for the release of Quality Engineering documentation.   
• Other duties and responsibilities as assigned. 

Qualifications:

Education/Experience

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Engineering degree and 5+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (10+years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)

Qualifications

• Ability to travel up to 5%. 
• Demonstrated self-starter with ability to work in a fast-paced environment. 
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint) 
• Strong verbal and technical writing capabilities (English language). 
• Expertise is problem solving and statistical techniques, GD&T, process validation, lean principles and Metrology. 
• Demonstrated ability to work in and lead teams through large scale projects. 

Preferred Skills

• ASQ CQE or CRE. 
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc. 
• Six Sigma Green or Black belt.    
• Certifications in DMIS programming preferred 
• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience. (ex: Aerospace, Defense, Pharmaceutical, etc.) 
• Knowledge and experience with external standards:  ISO 9000/9001, 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). 

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 manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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

Reporting to Department Manager, this position will have direct responsibility for the manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Example. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• 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 maintain safe working conditions and 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).
• Certification from a technical school program preferred.

Experience

• Minimum of 1-3 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.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• 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 30 pounds while moving tooling or tool holders. 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.

First Shift: Mon-Fri 6 am to 4:30 pm
48 hours

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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

Reporting to Department Manager, this position will have direct responsibility for the manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• 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 maintain safe working conditions and 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).
• Certification from a technical school program preferred.

Experience

• Minimum of 1-3 years’ experience with one of the following types of machines; Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.

Qualifications

• Able to read and understand a blue print.
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• 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.

Preferred Skills

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Class I, II and/or III Medical Device manufacturing experience.
• Knowledge of and experience with GMP/ISO standards.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
• 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 30 pounds while moving tooling or tool holders. 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.

Second Shift: 5:30PM-4:00AM
50 hours

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a driven and highly motivated Quality Engineering Technician 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 Inspection/Test Method development and improvement. This role will be expected to collaborate with Quality Engineering to support sustaining manufacturing and product development.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Programming automated metrology systems such as CMM’s and Vision Systems.
• Author Quality Inspection documentation such as Inspection Plans, with appropriate inspection methods and frequency rationales.
• Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Support the generation and maintenance of Process Control Plans.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Contribute to test method development and selection.
• Knowledge of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Assist in the execution and/or data collection of Test Method Validations and Gage R&R’s.
• Review standard inspection labor times for first article, first piece inspection, in-process and final inspection.
• Collaborate with Quality Engineering to identify and implement inspection cycle time reduction continuous improvement opportunities.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Support the generation of “redlines” for updates to Quality Engineering and Inspection documentation.
• Generate ECOs for the release of Quality Engineering documentation.
• Other duties and responsibilities as 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.

Qualifications

• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Knowledge of and the ability to read geometric dimensions and tolerances.
• Previous experience programming CMM’s and/or vision systems.
• 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.
• CMM operation, setup, and programing highly preferred.

Preferred Skills

• 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 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 manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist 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.

Shift: Fri-Sun; 6:00pm to 6:00am (with a paid break) and a 20% shift differential. Must be available for training M-F 5:30pm to 4:00am for a minimum of 2 weeks or until the candidate is able to successfully work independently.

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the manufacturing of components within a machining 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, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• 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 maintain safe working conditions and 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).
• Certification from a technical school program preferred.

Experience

• Minimum of 2-3 years’ experience in a regulated manufacturing environment.

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.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• 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 30 pounds while moving tooling or tool holders. 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.

Friday - Sunday: 6pm to 6am with a paid break
36hrs/extra shifts available

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.
• Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Champion First Article Inspections and Component Qualifications.
• Represent Quality Engineering in design reviews throughout the process development process.
• Support initial qualification audit activities (Customer and Regulatory Agencies).
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure compliance of all site personnel to site-level QMS and training requirements.
• May support the development of Quality Agreements for external customers.
• 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 4+ years of experience in a regulated manufacturing environment.

Preferred Skills/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).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
• 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.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III 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 setup and manufacture of components within a machining 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, setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to efficiently setup complex legacy components and basic new production orders and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, Vision system, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for complex machine or process issues.
• 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 maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program strongly preferred.

Experience

• Minimum of 3-7 years’ experience in a regulated manufacturing environment.

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.
• Advanced understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use hand-held tools to perform preventive maintenance or repair activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• 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.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

• Strong verbal and written English language communication skills.

Physical Requirements

• Occasionally lift/move up to 50 pounds this may be performed with assistants if needed.
• Prolonged periods of sitting.

TOMZ Corporation is looking to hire a highly motivated Quality 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. 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 is responsible for improving safety, quality, delivery, productivity, and cost by proactively improving the quality systems of the company. Through quality sciences, leading process improvement programs, and interaction with direct reports and key partners the Quality Manager will strive to continuously improve the process by leading a cross functional team of Quality Inspectors, Metrologists, Quality Engineer, and others to reduce risk, improve customer satisfaction and achieve quality at the source. The Quality Manager also manages the quality control function to ensure process compliance to the DMR and that medical devices are safe and effective.

Essential Functions

• Plans, directs, monitors, maintain, support and coordinate all of the activities in the Quality Control department.
• Creates and executes strategies to implement quality assurance and control at the source of process risk points.
• Manage flow of jobs going through the Quality Control department and coordinate scheduling priorities, and the need for inspection personnel.
• Manages the metrology team to build reliable, repeatable, and reproducible advance measurement techniques.
• Supports tiered management and helps the team resolve problems and escalates problems as appropriate.
• Provides guidance and mentoring to cross functional team to continuously strengthen the team to accomplish objectives and grow their careers.
• 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.
• 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.
• Approve or reject parts, components, assembly processes and finish products based on compliance and quality standards.
• Collaborate with team members to achieve company, business unit and team goal.
• 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.
• 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 and support Quality Systems Audits.
• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Other Duties as assigned.

Qualifications:

Education

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

Experience

• 3-5 years’ experience in a supervisorial/leadership role.
• 5+ years of Metrology experience

Qualifications

• Knowledge of GD&T and ISO13485 regulations.
• Ability to automatically pivot in a fast-paced work environment.
• Demonstrated organizational and project management skills.
• Effective communication and interpersonal skills.
• Microsoft Office.

Preferred Skills

• Visio, and Minitab are preferred.