Senior Medical Device Quality Inspection Lead

Job Description

Job Description

Role Overview

Step into a senior hands-on quality leadership role supporting precision manufacturing for medical devices at TOMZ. Reporting to quality leadership, you will guide daily quality control operations, uphold ISO 13485 documentation, and personally execute advanced inspections on high-precision machined parts, assemblies, and anodized components.

A Day in the Life

Your day starts by aligning the team’s priorities, setting targets, and clarifying expectations. You coach Quality Control personnel, provide input for performance appraisals, and step in to correct and elevate performance when needed. On the floor, you rotate across departments and production lines, adapting to different standards and teams to keep work moving seamlessly.

• Train and perform visual and layout inspections using microscopes, calipers, micrometers, and a range of gages to verify precise dimensions on machined components and assemblies.
• Own the creation, completion, and compilation of inspection documentation to maintain ISO 13485 standards, ensuring robust material control, identification, and traceability throughout the process.
• Verify conformance by reviewing Device History Records (DHRs) against the Device Master Record (DMR); enforce Good Documentation Practices (GDP) across Routers, Inspection Plans, and DHRs during production and at final lot release.
• Use ERP and QMS tools to record inspection activities, ensure traceability, and maintain strict record control, supporting both physical and electronic record retention.
• Conduct Incoming, In-Process, and Final Inspections; document nonconformities; drive and verify follow-up actions; and route materials to MRB when issues remain unresolved.
• Lead and supervise material sorting activities; ensure nonconforming conditions are rapidly identified and escalated.
• Operate advanced metrology: optical comparators, vision systems, and basic CMM; utilize contracers and automated inspection techniques.
• Provide basic programming assistance for complex inspection or test methods, enabling efficient, repeatable measurements.
• Execute First Piece and First Article Inspections (FAI) as assigned.
• Perform process audits to confirm adherence to procedures and standard work; evaluate process controls such as SPC, precontrol, tool life, and key process parameters; train others on these standards.
• Champion continuous improvement aligned with Quality Best Practices and GDP/GMP requirements while adhering to the TOMZ Quality Management System.
• Follow all safety protocols and PPE requirements at every step.

What You Bring

• Fluency in reading and interpreting blueprints, specifications, and procedures.
• Meticulous attention to detail and consistent on-time execution.
• Strong knowledge of dimensional, visual, and mechanical inspection practices.
• Proficiency with Microsoft Office and clear communication in English, written and verbal.
• Solid math skills and deep familiarity with measurement tools: micrometers, calipers, dial indicators, height gages, pin gages, and related hand tools.
• Experience in Class I, II, and/or III medical device manufacturing.
• Background in regulated industries (e.g., aerospace, defense, pharmaceutical).

Education and Experience

• High school diploma or GED required; directly transferable work experience accepted. Manufacturing or engineering discipline preferred.
• Minimum 5 years of experience in a regulated manufacturing setting, or a combination of education and experience that delivers equivalent capability.

Preferred Credentials

• Quality certifications such as ASQ CQT, QCI, or similar.
• Working knowledge of GMP and ISO frameworks.

Physical and Work Environment

• Capable of bending, stooping, squatting, kneeling, and lifting up to 50 lbs; team lift or mechanical aid required over 50 lbs.
• 20/20 vision (corrected or uncorrected) to effectively sort raw and nonconforming materials; fine motor dexterity for small to medium components.
• Exposure to oil, grease, process noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves may be required.
• Comfortable sitting or standing for extended periods and performing frequent keyboard/computer work.