Senior Dimensional Inspection Lead – Medical Devices

Big Lake, MN
Posted 4 days ago

Summary of Position

Report directly to quality leadership and take ownership of day-to-day quality control within the department at TOMZ. We manufacture high-precision, metal machined and assembled components with anodize processes for Medical Devices. As the Senior Dimensional Inspection Lead, you’ll keep ISO 13485 documentation current and perform both conventional and advanced inspections across incoming, in-process, and final stages.

A Day in the Life

You start by aligning the team’s priorities, setting measurable targets, and ensuring the right people are on the right inspections. You review Device History Records (DHRs) against the Device Master Record (DMR), confirm Good Documentation Practices (GDP) are being followed on routers, inspection plans, and DHRs, and release finished lots when all criteria are met. Throughout the day you’ll move between departments, tackling complex inspections with comparators, vision systems, and basic CMM operation—training others as you go. When nonconformances surface, you capture them in the ERP/QMS, drive follow-ups, and transfer unresolved issues to MRB. You’ll audit processes for conformance to procedures/standard work, support continuous improvement aligned to GDP/GMP, and keep physical and electronic records organized for retention.

Essential Functions

  • Lead, coach, and train Quality Control personnel; provide feedback and input to performance appraisals.
  • Plan, prioritize, and direct inspection workloads; set expectations for throughput and quality.
  • Perform inspections on machined components and assemblies using visual/layout techniques and tools: microscopes, calipers, micrometers, and gages.
  • Create, complete, and compile inspection documentation to ensure material control, identification, and traceability.
  • Verify DHR alignment to DMR; uphold GDP on Routers, Inspection Plans, and DHRs through final lot release.
  • Document activities and maintain traceability within ERP and QMS; control records accurately.
  • Execute Incoming, In-Process, and Final Inspections; record nonconformities and escalate to MRB when needed.
  • Perform and supervise material sorts; train others on sorting and inspection standards.
  • Use advanced metrology (comparator, vision systems, basic CMM operation; contracers and automated techniques) and provide basic programming assistance for inspection/test methods.
  • Conduct First Piece and FAI inspections as assigned.
  • Evaluate process controls (SPC, Precontrol, Tool Life, Process Parameter) and train teams on requirements.
  • Perform process audits to confirm conformance to procedures and standard work.
  • Support continuous improvement and adhere to the TOMZ Quality Management System.
  • Follow safety and health practices including PPE requirements; support other Quality functions as needed; perform other duties as assigned.

Qualifications:

Education

  • High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

  • Minimum of 5 years’ experience in a regulated manufacturing environment, or equivalent education and experience.

Qualifications

  • Fluent reading of blueprints, specifications, and procedures; strong attention to detail and on-time execution.
  • Knowledge of dimensional, visual, and mechanical inspection processes.
  • Competent with Microsoft Office; capable of independent and team-based work.
  • Strong verbal and written English communication; basic math proficiency.
  • Hands-on expertise with mechanical measurement tools: micrometers, calipers, dial indicators, height gages, pin gages, etc.
  • Experience in Class I, II, and/or III Medical Device manufacturing.
  • Background in regulated industries (Aerospace, Defense, Pharmaceutical, etc.).

Preferred Skills

  • Quality certifications (ASQ CQT, QCI, etc.).
  • Knowledge of and experience with GMP/ISO standards, including ISO 13485.

Physical Demands

  • Ability to bend, stoop, squat, kneel, and lift up to 50 pounds (team lift or mechanical assistance required over 50 pounds).
  • 20/20 vision (assisted or unassisted) for sorting raw and non-conforming materials; good dexterity for small to medium parts.
  • Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
  • Ability to sit or stand for prolonged periods; frequent computer and keyboard use.

Machines & Technologies You Will Use

  • Coordinate Measuring Machine (CMM) (Zeiss)
  • Measurement Gauges
  • Calipers and Micrometers

$27 – $32 an hour