Senior Quality Control Inspector, Precision Machining (ISO 13485)

Job Description

Job Description

Shape What’s Possible in Medical Device Quality

At TOMZ, we manufacture high-precision metal components and assemblies for medical devices—including machining, assembly, and anodize operations. As the Senior Quality Control Inspector, you will report to quality leadership and take direct ownership of departmental quality control activities. You’ll maintain ISO 13485 documentation, ensure airtight traceability, and execute inspections using conventional layout methods and advanced metrology tools.

What You’ll TackleLeadership & Coaching

• Lead by example—train, mentor, and guide Quality Control personnel.
• Set priorities and performance targets; provide coaching and input to appraisals.
• Supervise inspection and sorting activities; clarify standards and requirements.

Inspection Excellence

• Conduct incoming, in-process, final, and First Article (FAI/First Piece) inspections.
• Use microscopes, calipers, micrometers, gages, comparators, vision systems, contracers, and basic CMM programs to verify compliance.
• Perform complex inspections and offer basic programming support for inspection/test methods.

Documentation & Compliance

• Create and compile inspection documentation; manage material control, identification, and traceability.
• Review DHRs against the DMR; ensure GDP for Routers, Inspection Plans, and DHRs throughout manufacturing and final lot release.
• Use ERP and QMS systems to record activities and maintain records under strict control.

Nonconformance Management

• Record and track nonconformities; coordinate follow-up actions; move materials into MRB when unresolved.
• Lead material sorts to segregate nonconforming product.

Continuous Improvement & Audits

• Champion continuous improvement aligned with GDP/GMP and quality best practices.
• Perform process audits and evaluate process controls (SPC, precontrol, tool life, process parameters); train teams on process standards.

Cross-Functional Agility

• Adapt to varying standards, production lines, and teams; support other Quality functions and both physical/electronic record retention.
• Consistently adhere to the TOMZ Quality Management System and safety/PPE requirements.

What You Bring

• Ability to read/interpret blueprints, specifications, and procedures.
• Knowledge of dimensional, visual, and mechanical inspection processes.
• Exceptional accuracy, attention to detail, and timely execution; strong English communication.
• Microsoft Office proficiency; solid math capability.
• Deep hands-on experience with micrometers, calipers, dial indicators, height and pin gages.
• Background in regulated manufacturing: Medical Device (Class I/II/III), Aerospace, Defense, or Pharmaceutical.

Education & Experience

• High school diploma, GED, or equivalent directly transferrable experience (Manufacturing or Engineering discipline preferred).
• At least 5 years of experience in a regulated manufacturing environment, or equivalent education/experience.

Preferred Qualifications

• Quality certifications (ASQ CQT, QCI) and knowledge of GMP/ISO standards.

Physical Requirements & Work Conditions

• Bend, stoop, squat, kneel; lift up to 50 lbs (team/mechanical assist over 50 lbs).
• 20/20 vision (assisted or unassisted); fine dexterity for small/medium components.
• Exposure to oil, grease, noise, solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE may include safety glasses, dust masks, ear plugs, and cut/chemical-resistant gloves.
• Ability to sit or stand for extended periods; frequent computer/keyboard use.

Tools & Tech You’ll Use

• Zeiss CMM
• Comparators, vision systems, contracers
• Measurement gages, calipers, micrometers