Quality Systems & Metrology Specialist — Medical Device Components

Is this you?

Do you take pride in catching the micron-level details others miss? Can you coach a teammate through a complex inspection while building a basic CMM routine—and still keep ISO 13485 documentation spotless? If so, you might be the Quality Systems & Metrology Specialist we’re looking for.

In this role, you report to quality leadership and carry direct responsibility for department-level quality control. Our components are created through precision metal machining, assembly, and anodize processes for medical devices—and your work ensures they meet every requirement.

What you will do

• Lead and train: Provide day-to-day leadership for QC personnel, clarify standards, correct course when needed, and contribute input to performance appraisals.
• Plan the work: Prioritize inspection workloads, set targets, and align resources across lines and teams.
• Inspect with skill: Perform incoming, in-process, final, and First Piece/FAI inspections using visual/layout techniques, microscopes, calipers, micrometers, gages, comparators, vision systems, contracers, and basic Zeiss CMM operation.
• Elevate complexity: Conduct advanced inspections and offer basic programming support for complex inspection and test methods.
• Document rigorously: Create and compile inspection records; ensure material control, identification, and traceability at every step.
• Verify compliance: Review DHRs against the DMR; enforce GDP for Routers, Inspection Plans, and DHRs through manufacture and final lot release.
• Work in the systems: Use ERP and QMS to document activities, maintain control of records, and preserve traceability.
• Contain nonconformance: Record issues, drive follow-up, move parts into MRB if unresolved, and lead material sorts to protect the line and the customer.
• Improve continuously: Support CI aligned with GDP/GMP; run process audits; evaluate process controls (SPC, precontrol, tool life, process parameters) and train others on standards.
• Adapt and support: Shift between departments and product lines, assist other Quality functions, and help retain both physical and electronic records.
• Champion the system: Follow safety/PPE rules and adhere to the TOMZ Quality Management System.

What you bring

• Fluency with blueprints, specifications, and procedures.
• Proven capability in dimensional, visual, and mechanical inspection methods.
• Accuracy, urgency, and exceptional attention to detail; effective written and verbal English communication.
• Microsoft Office proficiency and solid math fundamentals.
• Strength with precision tools: micrometers, calipers, dial indicators, height and pin gages.
• Experience in regulated manufacturing—Medical Device (Class I/II/III), Aerospace, Defense, or Pharmaceutical.

Education & Experience

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Minimum 5 years in a regulated manufacturing environment, or equivalent education/experience.

Preferred extras

• ASQ CQT, QCI, or similar certifications; working knowledge of GMP/ISO standards.

Physical realities of the job

• Frequent bending, stooping, squatting, and kneeling; lift up to 50 lbs (use team/mechanical assist above 50 lbs).
• 20/20 vision (corrected or uncorrected) for sorting raw and nonconforming materials; fine motor skills for small to medium parts.
• Shop-floor exposure: oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, sharp edges; PPE such as safety glasses, masks, ear plugs, and cut/chemical-resistant gloves may be required.
• Extended periods of standing or sitting; frequent computer and keyboard use.

Tools & technologies

• Zeiss Coordinate Measuring Machine (CMM)
• Comparators, vision systems, contracers
• Measurement gages, calipers, micrometers