Precision Quality Cell Supervisor — Medical Device Machining

Overview

Based in Big Lake, MN and reporting to the Quality Manager, you will own the quality control function for a production cell at TOMZ. Our site manufactures medical device components through high-precision metal machining, assembly, and passivation/anodize processes. You will maintain ISO 13485 standards documentation, serve as the on-floor quality point of contact, and spearhead continuous improvement within the cell.

A day in this role

• Kick off by reviewing ERP and QMS queues to prioritize inspections, product final acceptance, and shipments. Set clear targets, expectations, and align the team’s workload.
• Perform First Piece and FAI activities; complete Incoming and Final Inspections as assigned; and independently inspect at least 90% of products with expected proficiency and without outside support.
• Execute in-process visual and layout inspections using microscopes, calipers, micrometers, and gages; conduct complex inspections with comparators, CMM, vision systems, contracers, and automated techniques, providing basic programming assistance as needed.
• Ensure robust material control, identification, and traceability for both conforming and nonconforming product throughout manufacturing.
• Record nonconformances discovered in process, follow up to verify closure, move unresolved issues to MRB, coordinate containment, assist with root cause analysis, and support CAPA related to cell-level issues.
• Maintain ISO 13485 documentation; support physical and electronic record retention; and ensure Device History Records (DHRs) are executed per the Device Master Record (DMR — correct process and revision). Uphold GDP for Routers, Inspection Plans, and DHRs throughout manufacturing and before final lot release/shipment.
• Conduct process audits to confirm procedures and standard work are followed; coach and correct team members; provide input for performance evaluations; and train Quality Control personnel.
• Lead and support continuous improvement aligned with Quality Best Practices and GDP/GMP standards.
• Adhere to the TOMZ Quality Management System; follow all occupational Safety and Health requirements, including PPE guidance and rules; and support additional Quality Department needs as assigned.

Tools and systems you’ll use

• Microscopes, calipers, micrometers, dial indicators, height gages, pin gages, and other precision measurement tools
• Comparators, CMM, vision systems, contracers, and automated inspection methods (with basic programming assistance)
• ERP and QMS for prioritization, traceability, and documentation control

Qualifications

• Strong blueprint/specification/procedure reading capability with high attention to detail and timely task completion
• Hands-on expertise in dimensional, visual, and mechanical inspection processes
• Proficiency with Microsoft Office and effective verbal/written English communication
• Basic math competency and deep knowledge of mechanical measurement tools and their care
• Experience in Class I, II, and/or III medical device manufacturing
• Background in regulated industries (Aerospace, Defense, Pharmaceutical, etc.)
• Ability to work independently and as part of a team; capable of coaching, mentoring, and guiding others

Preferred

• Quality certifications (e.g., ASQ CQT, QCI)
• Working knowledge of GMP/ISO standards

Education & Experience

• High school diploma, GED, or equivalent directly transferrable work experience
• Minimum 6 years of experience in a regulated manufacturing environment, or equivalent education and experience

Core proficiencies

• Quality Inspection Experience
• ISO 13485
• Coaching and Mentoring Experience
• Precision Measurement & Inspection