Dimensional Metrology Lead - Medical Device Manufacturing

Role Overview Each day, you’ll arrive ready to be the go-to quality expert for high-precision, machined medical device components produced through metal machining, assembly, and anodize operations. Reporting to quality leadership, you’ll have direct responsibility for quality control activities in the department—owning ISO 13485 documentation and performing hands-on inspections using both conventional layout methods and advanced metrology equipment. A Day in the Life Kick off the shift by reviewing priorities in the ERP/QMS, aligning inspection work, and setting clear targets for your team. Lead a quick huddle to coach, assign work, and reinforce Good Documentation Practices (GDP) and safety/PPE expectations. Run First Piece and FAI activities; verify conformity using microscopes, comparators, calipers, micrometers, height and pin gages, vision systems, and basic CMM programs (Zeiss). Audit in-process work at the machines; evaluate process controls (SPC, precontrol, tool life, process parameters) and guide operators on standards. Review DHRs against the DMR, confirm GDP on Routers and Inspection Plans, and approve final lot release when requirements are met. Document nonconformances, coordinate follow-up actions, and move items to MRB when issues remain unresolved; lead material sort activities as needed. Update and maintain ISO 13485 documentation and quality records; ensure traceability and record control across all operations. Support continuous improvement aligned with GDP/GMP, run process audits, and provide basic programming assistance for complex inspection/test methods. Flex between production lines and departments to meet demand, supporting other Quality functions and both electronic and physical record retention. Your Impact Provide day-to-day leadership, training, and guidance to Quality Control personnel; coach performance and contribute input to appraisals. Uphold the TOMZ Quality Management System while ensuring safe work practices and proper PPE at all times. Safeguard product integrity for Class I, II, and III medical devices by maintaining rigorous inspection standards and traceability. Qualifications Proficiency reading blueprints, specifications, and procedures; strong knowledge of dimensional, visual, and mechanical inspection processes. Meticulous attention to detail, consistent accuracy, and timely task completion; strong English written and verbal communication. Competency with Microsoft Office; solid math skills. Advanced use and care of inspection tools including micrometers, calipers, dial indicators, height and pin gages. Experience in regulated manufacturing such as Medical Devices (Class I/II/III), Aerospace, Defense, or Pharmaceutical. Education & Experience High school diploma, GED, or directly transferrable work experience (Manufacturing or Engineering discipline preferred). Minimum 5 years of experience in a regulated manufacturing environment, or an equivalent combination of education and experience. Preferred Quality certifications (e.g., ASQ CQT, QCI) and familiarity with GMP/ISO standards. Physical & Work Environment Ability to bend, stoop, squat, kneel, and lift up to 50 lbs. Team lift or mechanical assist required for items over 50 lbs. 20/20 vision (corrected or uncorrected) for sorting raw and nonconforming material; good dexterity for small to medium parts. Exposure to oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE such as safety glasses, masks, ear plugs, and cut/chemical-resistant gloves may be required. Ability to sit or stand for long periods and perform frequent keyboard/computer work. Tools & Technologies Coordinate Measuring Machine (CMM) — Zeiss Comparators and vision systems; measurement gages Calipers and micrometers #J-18808-Ljbffr TOMZ Manufacturing Corp