Senior Metrology & Compliance Specialist (ISO 13485)

Job Description

Job Description

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.

• Elevate product confidence through rigorous incoming, in-process, and final inspections.
• 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.

• 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. Train the team on these controls.
• 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.

• 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).
• Ability to contribute independently and in teams within a regulated environment.
• 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.

• High school diploma or GED, or directly transferable experience; Manufacturing or Engineering focus preferred.

• 5+ years in regulated manufacturing, or equivalent education/experience blend.

• ASQ certifications (CQT, QCI, etc.).
• Hands-on application of GMP and ISO standards.

• Capable of bending, stooping, squatting, kneeling, and lifting up to 50 lbs (team/mechanical assist above 50 lbs).
• 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.