Lead Metrology & Inspection Specialist -- ISO 13485 Operations

Is this you?

Do you thrive as the go-to quality expert on a busy production floor? Can you independently inspect the vast majority of machined parts, guide a team, and keep ISO 13485 documentation rock solid? If you’re nodding yes, TOMZ in Big Lake, MN wants you to lead a quality cell supporting high-precision metal machining, assembly, and passivation/anodize for medical devices.

What you’ll tackle

• Be the point person for quality issues on the production floor, triaging concerns quickly and driving resolution.
• Execute Incoming and Final Inspection, plus First Piece and FAI activities, ensuring product acceptance is accurate and on time.
• Perform visual/layout inspections using microscopes, calipers, micrometers, and gages; handle complex checks using comparators, CMM, vision systems, contracers, and automated techniques—providing basic programming assistance when needed.
• Independently inspect at least 90% of product with the expected proficiency, without supervision or outside support.
• Keep material identification, control, and traceability watertight for conforming and nonconforming items throughout all stages.
• Capture nonconformities; verify containment and corrective actions; move unresolved issues to MRB; assist with root cause analysis; and support CAPA for cell-level problems.
• Use ERP and QMS to prioritize inspections, support product final acceptance and shipment, and ensure inspection and traceability records are complete and controlled.
• Maintain ISO 13485 standards documentation; support physical/electronic record retention; and confirm DHRs are executed per DMR (correct process and revision) with GDP enforced for Routers, Inspection Plans, and DHRs across manufacturing and prior to final lot release/shipment.
• Audit processes against procedures/standard work; lead continuous improvement aligned to Quality Best Practices and GDP/GMP; coach, correct, and train QC personnel; and provide input for performance evaluations.
• Follow the TOMZ Quality Management System and all occupational Safety and Health/PPE requirements. Support additional Quality functions as assigned.

How you’ll lead

• Set clear expectations and targets for the cell; align and reprioritize workload as conditions change.
• Mentor peers, build inspection capability, and share best practices in metrology and documentation.

What you’ll bring

• Excellent blueprint/specification reading skills; meticulous attention to detail; reliable follow-through
• Practical knowledge of dimensional, visual, and mechanical inspection processes
• Fluency with Microsoft Office; effective English communication (verbal and written)
• Comfort with math relevant to inspection and measurement
• Deep familiarity with precision measurement tools (micrometers, calipers, indicators, height/pin gages, etc.)
• Experience with Class I, II, and/or III medical device manufacturing
• Background in regulated sectors such as Aerospace, Defense, or Pharmaceutical
• Ability to work autonomously and collaboratively, with proven coaching/mentoring experience

Bonus points

• ASQ certifications (CQT, QCI) or similar
• Demonstrated experience with GMP/ISO standards

Education & experience

• High school diploma, GED, or equivalent directly transferrable work experience
• At least 6 years in a regulated manufacturing environment, or equivalent education/experience

Where you’ll sit in the org

Reporting to the Quality Manager at TOMZ Big Lake, MN, you’ll anchor the quality function for your cell and partner closely with operations to keep product flowing to customers, right the first time.