Advanced Precision Quality Specialist, Machined Components

Join the mission

Every component we release can influence a patient’s outcome. As an Advanced Precision Quality Specialist at TOMZ, you will be a frontline guardian of compliance and accuracy for medical device components manufactured through high‑precision machining, assembly, and anodizing.

The challenge

1. Lead with clarity: Organize daily workload, define measurable goals, and mentor Quality Control teammates—coaching, correcting, and contributing to performance appraisals.
2. Inspect with rigor: Perform and teach visual/layout inspections using microscopes, calipers, micrometers, and gages; execute advanced measurements via comparators, vision systems, contracers, and basic CMM.
3. Document without compromise: Build and maintain ISO 13485 documentation; ensure robust material control, identification, and full traceability.
4. Prove conformance: Review DHRs against the DMR; enforce GDP on Routers, Inspection Plans, and DHRs during production and at final lot release.
5. Make data count: Capture inspection results in ERP and QMS systems; preserve electronic and physical records with strict control and traceability.
6. Contain risk fast: Execute Incoming, In‑Process, and Final Inspections; record nonconformities; verify corrective follow‑up; escalate to MRB when necessary; oversee sorting to isolate issues.
7. Automate smartly: Provide basic programming support for complex inspection and test routines to streamline repeatability and throughput.
8. Validate firsts: Conduct First Piece and First Article Inspections (FAI) to qualify setups and processes.
9. Audit and improve: Run process audits to confirm adherence to procedures/standard work; evaluate SPC, precontrol, tool life, and process parameters; teach best practices; drive CI aligned with GDP/GMP.
10. Be everywhere: Move between departments and production lines as needed, bringing a proactive approach and unwavering safety mindset while following PPE requirements.
11. Honor the system: Adhere to the TOMZ Quality Management System and support other quality functions and record retention as assigned.

Your profile

• Expert at interpreting blueprints, specifications, and procedures.
• Relentless attention to detail and timely task execution.
• Hands‑on mastery of dimensional, visual, and mechanical inspection processes.
• Proficient with Microsoft Office; strong English communication skills (written and verbal).
• Solid math foundation and deep experience with micrometers, calipers, dial indicators, height and pin gages, and related precision hand tools.
• Background in Class I, II, and/or III medical device manufacturing and experience within regulated industries such as aerospace, defense, or pharmaceutical.

Education and tenure

• High school diploma or GED (or directly transferable experience); manufacturing/engineering discipline preferred.
• 5+ years in regulated manufacturing, or equivalent education plus experience.

Preferred extras

• ASQ CQT, QCI, or comparable quality certifications.
• Applied knowledge of GMP and ISO standards.

Physical requirements and environment

• Ability to bend, stoop, squat, and kneel; lift up to 50 lbs (use team lift/mechanical assist for heavier items).
• 20/20 vision (assisted or unassisted) needed to sort raw and nonconforming materials; steady dexterity for small to medium parts.
• Regular exposure to oils, grease, shop noise, cleaning agents, dust, metal particulates, sparks, coolants, and sharp edges; PPE like safety glasses, dust masks, ear plugs, and cut‑/chemical‑resistant gloves may be required.
• Comfort with extended standing or sitting and frequent computer/keyboard activity.