Quality Inspector II - ISO 13485 Medical Devices

TOMZ Corporation; Big Lake (MN); On-site; USD 52,000 - 66,000; Full time

Job summary

TOMZ Corporation in Minnesota seeks a Quality Control Inspector to oversee inspection activities within the department for medical device manufacturing. The role emphasizes adherence to ISO 13485, GDP/GMP, and proper documentation of inspections on machined components using conventional layout techniques and equipment.

Responsibilities include performing complex inspections with CMM and gauges, ensuring material traceability, maintaining accurate records in ERP/QMS, and generating COCs and

Qualifications

• 3–5 years of experience in a regulated manufacturing environment.
• Reading blueprints and procedures; using gauges and metrology equipment.
• Knowledge of GDP/GMP and ISO 13485 standards.

Responsibilities

• Perform complex inspections on machined components using CMMs and gauges.
• Provide training for inspections on machined components using visual/layout techniques.
• Execute Incoming, First Piece, FAI, In-process, and Final inspections.
• Compile and maintain documentation related to Quality Inspection standards.
• Ensure material control, identification and traceability is maintained.
• Review GDP compliance for DHRs, routers and device history records.
• Support ERP and QMS documentation activities; assist in final acceptance and shipments.
• Generate Packing Slips and Certificates of Compliance as required.
• Adhere to PPE and safety rules; support record retention.

Skills

Blueprint reading

Dimensional measurement

Quality documentation

Attention to detail

Teamwork

English communication

Education

High school diploma or GED

Job description

TOMZ Corporation in Minnesota seeks a Quality Control Inspector to oversee inspection activities within the department for medical device manufacturing. The role emphasizes adherence to ISO 13485, GDP/GMP, and proper documentation of inspections on machined components using conventional layout techniques and equipment.

Responsibilities include performing complex inspections with CMM and gauges, ensuring material traceability, maintaining accurate records in ERP/QMS, and generating COCs and