Lead Dimensional Quality Inspector — Medical Device Machining

Shape reliability at TOMZ as our Lead Dimensional Quality Inspector

Your day starts on the production floor, checking in with machinists and fellow inspectors. You set priorities, align workloads, and coach the team so every critical tolerance is verified the first time. By mid-morning, you’re deep into a first-article inspection for a new medical device component, validating features with microscopes, calipers, micrometers, comparators, a vision system, and basic CMM routines you help program. After lunch, you review Device History Records against the Device Master Record, confirm Good Documentation Practices on routers and inspection plans, record findings in our ERP/QMS, and move unresolved issues to MRB. Before you wrap, you run a quick process audit on SPC and tool-life controls and train a teammate on precontrol limits.

What you will do

• Lead, mentor, and train Quality Control personnel; set expectations, balance workload, and provide coaching and corrective guidance.
• Contribute feedback for performance reviews and support skill development across the team.
• Perform incoming, in-process, and final inspections on machined components and assemblies using visual/layout methods and precision tools (microscopes, calipers, micrometers, dial indicators, height and pin gages).
• Execute complex inspections using comparators, vision systems, contracers, and basic CMM operations; provide basic programming assistance for automated/advanced inspection routines.
• Create, maintain, and compile inspection documentation to ISO 13485 standards; ensure material control, identification, and traceability from receipt to final lot release.
• Verify GDP is followed for routers, inspection plans, DHRs, and related records; review DHRs for alignment with DMRs.
• Record inspection activity in ERP/QMS, preserving traceability and record integrity; support physical and electronic record retention.
• Identify and document nonconformances, ensure follow-up actions, and route materials to MRB when required; perform material sorts as needed.
• Conduct process audits to confirm procedures and standard work are followed; evaluate SPC, precontrol, tool-life, and process parameter adherence and train others on these controls.
• Champion continuous improvement in line with GDP/GMP and Quality Best Practices; adhere to the TOMZ Quality Management System.
• Adapt across lines and departments to meet shifting priorities; support additional Quality functions as needed.
• Perform first-piece and first-article inspections (FAI) to qualify setups and validate new or revised parts.
• Follow all safety and health rules, including PPE requirements.
• Other duties as assigned.

What you bring

• Expertise reading blueprints, specifications, and procedures; strong attention to detail with timely follow-through.
• Knowledge of dimensional, visual, and mechanical inspection methods and practices.
• Proficiency with Microsoft Office and the ability to document clearly in English (written and verbal).
• Comfort working independently and collaboratively in a fast-paced, regulated environment.
• Solid math skills and deep hands-on experience with precision measurement tools (micrometers, calipers, indicators, height/pin gages, etc.).
• Experience in Class I, II, and/or III medical device manufacturing; background in regulated industries such as aerospace, defense, or pharmaceutical.

Education

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

Experience

• At least 5 years in a regulated manufacturing setting, or a combination of education and experience providing equivalent proficiency.

Preferred

• Quality certifications (ASQ CQT, QCI, or similar).
• Familiarity with and application of GMP/ISO standards.

Physical demands and work environment

• Able to bend, stoop, squat, kneel, and lift up to 50 lbs (team lift or mechanical assist over 50 lbs).
• 20/20 vision, with or without correction, for sorting raw and nonconforming material; fine motor dexterity for small-to-medium components.
• Exposure to oils, grease, industrial noise, solvents, dust, metal chips, sparks, coolants, and sharp edges; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves may be required.
• Prolonged standing or sitting as tasks demand; frequent computer and keyboard use.