Quality Inspector II

4 weeks ago

Berlin, United States TOMZ Corporation Full time

TOMZ Corporation is in search of a Quality Inspector to join our team A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Some of 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:

Reporting to the 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 · Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques. Faced paced work environment.


ESSENTIAL FUNCTIONS:

· 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.

-Other duties as required as outlined in full job description.


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.

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