Quality Systems & Metrology Specialist — Medical Device Components

Is this you?Do you take pride in catching the micron-level details others miss? Can you coach a teammate through a complex inspection while building a basic CMM routine—and still keep ISO 13485 documentation spotless? If so, you might be the Quality Systems & Metrology Specialist we’re looking for.In this role, you report to quality leadership and carry direct responsibility for department-level quality control. Our components are created through precision metal machining, assembly, and anodize processes for medical devices—and your work ensures they meet every requirement.What you will doLead and train: Provide day-to-day leadership for QC personnel, clarify standards, correct course when needed, and contribute input to performance appraisals.Plan the work: Prioritize inspection workloads, set targets, and align resources across lines and teams.Inspect with skill: Perform incoming, in-process, final, and First Piece/FAI inspections using visual/layout techniques, microscopes, calipers, micrometers, gages, comparators, vision systems, contracers, and basic Zeiss CMM operation.Elevate complexity: Conduct advanced inspections and offer basic programming support for complex inspection and test methods.Document rigorously: Create and compile inspection records; ensure material control, identification, and traceability at every step.Verify compliance: Review DHRs against the DMR; enforce GDP for Routers, Inspection Plans, and DHRs through manufacture and final lot release.Work in the systems: Use ERP and QMS to document activities, maintain control of records, and preserve traceability.Contain nonconformance: Record issues, drive follow-up, move parts into MRB if unresolved, and lead material sorts to protect the line and the customer.Improve continuously: Support CI aligned with GDP/GMP; run process audits; evaluate process controls (SPC, precontrol, tool life, process parameters) and train others on standards.Adapt and support: Shift between departments and product lines, assist other Quality functions, and help retain both physical and electronic records.Champion the system: Follow safety/PPE rules and adhere to the TOMZ Quality Management System.What you bringFluency with blueprints, specifications, and procedures.Proven capability in dimensional, visual, and mechanical inspection methods.Accuracy, urgency, and exceptional attention to detail; effective written and verbal English communication.Microsoft Office proficiency and solid math fundamentals.Strength with precision tools: micrometers, calipers, dial indicators, height and pin gages.Experience in regulated manufacturing—Medical Device (Class I/II/III), Aerospace, Defense, or Pharmaceutical.Education & ExperienceHigh school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).Minimum 5 years in a regulated manufacturing environment, or equivalent education/experience.Preferred extrasASQ CQT, QCI, or similar certifications; working knowledge of GMP/ISO standards.Physical realities of the jobFrequent bending, stooping, squatting, and kneeling; lift up to 50 lbs (use team/mechanical assist above 50 lbs).20/20 vision (corrected or uncorrected) for sorting raw and nonconforming materials; fine motor skills for small to medium parts.Shop-floor exposure: oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, sharp edges; PPE such as safety glasses, masks, ear plugs, and cut/chemical-resistant gloves may be required.Extended periods of standing or sitting; frequent computer and keyboard use.Tools & technologiesZeiss Coordinate Measuring Machine (CMM)Comparators, vision systems, contracersMeasurement gages, calipers, micrometers #J-18808-Ljbffr Torrey Holistics