Senior Dimensional Inspection Lead Medical Devices

Job Description

Job Description

About the Role

Report directly to quality leadership and take ownership of day-to-day quality control within the department at TOMZ. We manufacture high-precision, metal machined and assembled components with anodize processes for Medical Devices. As the Senior Dimensional Inspection Lead, you’ll keep ISO 13485 documentation current and perform both conventional and advanced inspections across incoming, in-process, and final stages.

A Day in the Life

You start by aligning the team’s priorities, setting measurable targets, and ensuring the right people are on the right inspections. You review Device History Records (DHRs) against the Device Master Record (DMR), confirm Good Documentation Practices (GDP) are being followed on routers, inspection plans, and DHRs, and release finished lots when all criteria are met. Throughout the day you’ll move between departments, tackling complex inspections with comparators, vision systems, and basic CMM operation—training others as you go. When nonconformances surface, you capture them in the ERP / QMS, drive follow-ups, and transfer unresolved issues to MRB. You’ll audit processes for conformance to procedures / standard work, support continuous improvement aligned to GDP / GMP, and keep physical and electronic records organized for retention.

What You'll Own

• Lead, coach, and train Quality Control personnel; provide feedback and input to performance appraisals.
• Plan, prioritize, and direct inspection workloads; set expectations for throughput and quality.
• Perform inspections on machined components and assemblies using visual / layout techniques and tools : microscopes, calipers, micrometers, and gages.
• Create, complete, and compile inspection documentation to ensure material control, identification, and traceability.
• Verify DHR alignment to DMR; uphold GDP on Routers, Inspection Plans, and DHRs through final lot release.
• Document activities and maintain traceability within ERP and QMS; control records accurately.
• Execute Incoming, In-Process, and Final Inspections; record nonconformities and escalate to MRB when needed.
• Perform and supervise material sorts; train others on sorting and inspection standards.
• Use advanced metrology (comparator, vision systems, basic CMM operation; contracers and automated techniques) and provide basic programming assistance for inspection / test methods.
• Conduct First Piece and FAI inspections as assigned.
• Evaluate process controls (SPC, Precontrol, Tool Life, Process Parameter) and train teams on requirements.
• Perform process audits to confirm conformance to procedures and standard work.
• Support continuous improvement and adhere to the TOMZ Quality Management System.
• Follow safety and health practices including PPE requirements; support other Quality functions as needed; perform other duties as assigned.

Qualifications

Education

Experience

Preferred

Physical Demands & Work Environment

Machines & Technologies You’ll Use