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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 Lead with clarity:

Organize daily workload, define measurable goals, and mentor Quality Control teammates—coaching, correcting, and contributing to performance appraisals.

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.

Document without compromise:

Build and maintain

ISO 13485

documentation; ensure robust material control, identification, and full traceability.

Prove conformance:

Review DHRs against the DMR; enforce GDP on Routers, Inspection Plans, and DHRs during production and at final lot release.

Make data count:

Capture inspection results in ERP and QMS systems; preserve electronic and physical records with strict control and traceability.

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.

Automate smartly:

Provide basic programming support for complex inspection and test routines to streamline repeatability and throughput.

Validate firsts:

Conduct First Piece and First Article Inspections (FAI) to qualify setups and processes.

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.

Be everywhere:

Move between departments and production lines as needed, bringing a proactive approach and unwavering safety mindset while following PPE requirements.

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.