ISO 13485 Inspection & Compliance Lead

Job Description

Job DescriptionRole at a Glance

Drive quality control execution and compliance for a precision medical device manufacturer. Reporting to quality leadership, you will lead inspections, maintain ISO 13485 documentation, and ensure airtight traceability across machining, assembly, and anodize operations.

Why This Role Matters

• Safeguards patient safety and product reliability through rigorous inspection and documentation.
• Ensures alignment between DHRs and the DMR, enabling confident lot release.
• Builds team capability through training, coaching, and process audits.

Core Responsibilities

• Leadership & Planning: Align and prioritize workload; set targets and expectations; coach/correct as needed; provide input to performance appraisals.
• Inspection Mastery: Perform incoming, in-process, and final inspections using visual/layout techniques and tools (microscopes, calipers, micrometers, gages); conduct First Piece and full FAI inspections.
• Advanced Metrology: Operate comparators, vision systems, and perform basic CMM operation; utilize contracers and automated methods; provide basic programming assistance for inspection/test methods.
• Quality Systems & Documentation: Create and compile inspection documentation; ensure material control, identification, and traceability; document activities in ERP and QMS; uphold GDP on Routers, Inspection Plans, and DHRs.
• Compliance & Release: Review DHRs for conformance to the DMR and release final lots when criteria are met.
• Nonconformance Control: Record nonconformities, drive follow-up actions, and move materials to MRB when issues remain unresolved; supervise and train others on sorting activities.
• Continuous Improvement: Support initiatives aligned with GDP/GMP; perform process audits to verify adherence to procedures and standard work; evaluate and train on SPC, Precontrol, Tool Life, and Process Parameter controls.
• Cross-Functional Flexibility: Adapt to varying quality standards, production lines, and teams; support other Quality Department functions; manage physical and electronic record retention; adhere to the TOMZ Quality Management System; follow safety and PPE requirements; perform other duties as assigned.

Must-Have Qualifications

• Proficiency reading blueprints, specifications, and procedures; consistent accuracy and timeliness.
• Knowledge of dimensional, visual, and mechanical inspection processes.
• Microsoft Office competency; effective independent contributor and team collaborator.
• Strong English verbal and written communication; solid basic math.
• Deep experience with mechanical measurement tools: micrometers, calipers, dial indicators, height gages, pin gages, etc.
• Experience with Class I, II, and/or III Medical Devices.
• Background in regulated manufacturing (Aerospace, Defense, Pharmaceutical, etc.).

Education

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

Experience

• 5+ years in a regulated manufacturing environment, or equivalent education and experience.

Preferred Credentials

• Quality certifications: ASQ CQT, QCI, etc.
• GMP/ISO familiarity, including ISO 13485.

Physical Demands & Environment

• Bend, stoop, squat, kneel, and lift up to 50 lbs (team lift or mechanical assist required above 50 lbs).
• 20/20 vision (assisted or unassisted) for sorting; dexterity for small to medium products.
• Exposure to oil, grease, noise, solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Prolonged standing/sitting; frequent keyboard and computer use.

Equipment You'll Use

• Coordinate Measuring Machine (CMM) (Zeiss)
• Measurement Gauges
• Calipers and Micrometers