Quality Inspector II

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

Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques. Perform and provide training assistance for 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 as assigned.

QUALIFICATIONS

Education

High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred). Experience Minimum of 3-5 years’ experience in a regulated manufacturing environment.

Qualifications

Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.) Ability to effectively read and understand blueprints, specifications and procedures. Knowledge of dimensional, visual and mechanical inspection processes. 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.

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. Strong verbal and written English language communication skills. Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).

Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

Quality certification(s) (e.g. ASQ CQT, QCI, etc.). Class I, II and/or III Medical Device manufacturing experience. Knowledge of and experience with GMP/ISO standards.