Senior Metrology & Compliance Specialist (ISO 13485)

Das ist der Job

Why this role matters Elevate product confidence through rigorous incoming, in-process, and final inspections.

Darum lohnt es sich

Train the team on these controls. Ability to contribute independently and in teams within a regulated environment. Physical requirements Capable of bending, stooping, squatting, kneeling, and lifting up to 50 lbs (team/mechanical assist above 50 lbs).

Be the quality multiplier at TOMZ At TOMZ, we manufacture high-precision metal components, assemblies, and anodized parts for medical devices.

As our Senior Metrology & Compliance Specialist, you will be the go-to expert who ensures every feature we machine is verified, documented, and released in full compliance with ISO 13485 and our Quality Management System. Safeguard traceability and documentation integrity from raw material to lot release.

Develop people and process capability through training, coaching, and audits. Advance continuous improvement aligned with GDP/GMP and Quality Best Practices. What you’ll tackle Lead and mentor QC personnel: set priorities, create performance targets, coach, and provide input for appraisals.

Execute visual and layout inspections with microscopes, calipers, micrometers, dial indicators, height/pin gages, and other precision tools. Perform complex dimensional checks using comparators, vision systems, contracers, and basic CMM operation; assist with basic programming for automated/advanced measurement routines.

Complete and maintain ISO 13485 documentation; ensure material control, identification, and full traceability. Validate GDP for routers, inspection plans, and DHRs; confirm DHRs align with the DMR. Log inspections and results within ERP and QMS; maintain accurate, controlled records and support record retention (physical and electronic).

Record nonconformities, drive follow-up actions, and move materials into MRB when issues persist; coordinate and supervise sorting activities. Audit processes to verify procedures and standard work adherence; evaluate SPC, precontrol, tool-life, and process parameters. Conduct First Piece and FAI inspections to qualify setups and new/revised parts.

Adapt across production lines and departments to meet dynamic priorities while following all safety/PPE requirements. Support additional Quality Department responsibilities and adhere to the TOMZ QMS. What you bring Fluency in reading and interpreting prints, specs, and procedures; meticulous attention to detail with on-time execution.

Knowledge of dimensional/visual/mechanical inspection methods and practices. Microsoft Office proficiency; strong English communication skills (verbal and written). Math competency and deep familiarity with precision measurement tools.

Experience in Class I, II, and/or III medical device manufacturing; plus background in regulated sectors (aerospace, defense, pharma) is valuable. Education High school diploma or GED, or directly transferable experience; Manufacturing or Engineering focus preferred.

Experience 5+ years in regulated manufacturing, or equivalent education/experience blend. Bonus qualifications ASQ certifications (CQT, QCI, etc.). Hands-on application of GMP and ISO standards. Ability to see 20/20 with or without correction for sorting tasks; strong dexterity for handling small to medium parts.

Comfort with manufacturing exposures (oils, grease, noise, solvents, dust, chips, sparks, coolants, sharp edges) and PPE usage (safety glasses, masks, ear protection, cut/chemical-resistant gloves) as needed. Prolonged standing or sitting; frequent computer/keyboard use.