ISO 13485 Metrology & Quality Control Supervisor

Job Description

Job Description

Why this role?

Do you thrive where precision, documentation, and leadership meet? At TOMZ, we craft high-precision machined components, assemblies, and anodized parts for medical devices. We’re seeking a supervisor who blends advanced inspection skills with team coaching and ISO 13485 stewardship.

What will you tackle?

• Set priorities for the Quality Control team, establish performance targets, and mentor inspectors—providing coaching and corrective guidance as needed.
• Train others and perform inspections using microscopes, calipers, micrometers, and gages, as well as comparators, vision systems, contracers, and basic CMM.
• Create and compile inspection documentation that supports ISO 13485, material identification, control, and full traceability.
• Review DHRs for alignment with the DMR; maintain GDP across Routers, Inspection Plans, and DHRs from build through final lot release.
• Leverage ERP and QMS systems to log inspections, manage records, and preserve traceability; support both physical and electronic record retention.
• Execute Incoming, In‑Process, and Final Inspections; record nonconformities; ensure timely follow‑ups; move items to MRB if issues persist.
• Run and oversee sorts to contain nonconforming material.
• Provide basic programming support for complex inspection/test methods.
• Complete First Piece and FAI activities.
• Audit processes to verify adherence to procedures and standard work.
• Assess process controls (SPC, precontrol, tool life monitoring, and critical parameters) and teach these methods to others.
• Advance continuous improvement, aligning with GDP/GMP and TOMZ’s Quality Management System.
• Flex across departments and production lines; follow all safety and PPE requirements.

What do you need to succeed?

• Ability to interpret engineering drawings, specifications, and procedures accurately.
• Precision mindset with strong attention to detail and timely completion of tasks.
• Hands‑on knowledge of dimensional, visual, and mechanical inspection methods.
• Comfort with Microsoft Office; clear English communication (written and verbal).
• Math competency and proficiency with micrometers, calipers, dial indicators, height and pin gages, and other precision tools.
• Background in medical device manufacturing (Class I/II/III) and experience in regulated sectors such as aerospace, defense, or pharma.

Education and Experience

• High school diploma or GED (or directly transferable experience); manufacturing or engineering focus preferred.
• At least 5 years in a regulated manufacturing environment, or equivalent education/experience blend.

What helps you stand out?

• ASQ CQT, QCI, or similar quality certifications.
• Practical exposure to GMP and ISO standards.

Physical realities of the job

• Frequent bending, stooping, squatting, kneeling; lift up to 50 lbs (team/mechanical assist over 50 lbs).
• 20/20 vision (with or without correction) for sorting raw and nonconforming materials; fine dexterity for handling small to medium parts.
• Work around oils, grease, industrial noise, solvents, dust, metal fines, sparks, coolants, and sharp materials; PPE such as safety glasses, masks, ear plugs, and cut‑ or chemical‑resistant gloves may be required.
• Long periods of standing or sitting; frequent computer and keyboard use.