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
