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.

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.

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