Precision Quality Cell Supervisor — Medical Device Machining

TOMZ Manufacturing Corp; Big Lake (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

TOMZ Manufacturing Corp in Big Lake, MN is seeking an on-floor Quality Control lead to own the QC function for a production cell. You will maintain ISO 13485 documentation, act as the on-floor QC contact, and drive continuous improvement in the cell.

Responsibilities include First Piece and FAI, in-process inspections with precision tools, and robust material control with traceability. 6+ years in regulated manufacturing and strong coaching abilities are preferred.

Qualifications

• Strong blueprint/spec reading and high attention to detail.
• Hands-on dimensional, visual, and mechanical inspection experience.
• Experience with ERP and QMS for traceability.
• Background in regulated manufacturing.
• Basic math competency.

Responsibilities

• Review ERP and QMS queues to prioritize inspections and shipments.
• Perform First Piece and FAI; complete Incoming/Final Inspections.
• Inspect at least 90% of products with required proficiency.
• Conduct in-process visual and dimensional inspections with tools.
• Record nonconformances; manage MRB and CAPA support.
• Maintain ISO 13485 documentation and DHRs.
• Lead continuous improvement and train QC personnel.
• Coach and mentor team; ensure GDP/GMP adherence.

Skills

Blueprint reading

Dimensional inspection

Mechanical measurement

Quality documentation

English communication

Leadership

Education

High school diploma, GED, or equivalent

Tools

Microscopes

Calipers

Micrometers

CMM

Vision systems

Contracers

Automated inspection

Job description

OverviewBased in Big Lake, MN and reporting to the Quality Manager, you will own the quality control function for a production cell at TOMZ. Our site manufactures medical device components through high-precision metal machining, assembly, and passivation/anodize processes. You will maintain ISO 13485 standards documentation, serve as the on-floor quality point of contact, and spearhead continuous improvement within the cell.A day in this roleKick off by reviewing ERP and QMS queues to prioritize inspections, product final acceptance, and shipments. Set clear targets, expectations, and align the team’s workload.Perform First Piece and FAI activities; complete Incoming and Final Inspections as assigned; and independently inspect at least 90% of products with expected proficiency and without outside support.Execute in-process visual and layout inspections using microscopes, calipers, micrometers, and gages; conduct complex inspections with comparators, CMM, vision systems, contracers, and automated techniques, providing basic programming assistance as needed.Ensure robust material control, identification, and traceability for both conforming and nonconforming product throughout manufacturing.Record nonconformances discovered in process, follow up to verify closure, move unresolved issues to MRB, coordinate containment, assist with root cause analysis, and support CAPA related to cell-level issues.Maintain ISO 13485 documentation; support physical and electronic record retention; and ensure Device History Records (DHRs) are executed per the Device Master Record (DMR — correct process and revision). Uphold GDP for Routers, Inspection Plans, and DHRs throughout manufacturing and before final lot release/shipment.Conduct process audits to confirm procedures and standard work are followed; coach and correct team members; provide input for performance evaluations; and train Quality Control personnel.Lead and support continuous improvement aligned with Quality Best Practices and GDP/GMP standards.Adhere to the TOMZ Quality Management System; follow all occupational Safety and Health requirements, including PPE guidance and rules; and support additional Quality Department needs as assigned.Tools and systems you’ll useMicroscopes, calipers, micrometers, dial indicators, height gages, pin gages, and other precision measurement toolsComparators, CMM, vision systems, contracers, and automated inspection methods (with basic programming assistance)ERP and QMS for prioritization, traceability, and documentation controlQualificationsStrong blueprint/specification/procedure reading capability with high attention to detail and timely task completionHands-on expertise in dimensional, visual, and mechanical inspection processesProficiency with Microsoft Office and effective verbal/written English communicationBasic math competency and deep knowledge of mechanical measurement tools and their careExperience in Class I, II, and/or III medical device manufacturingBackground in regulated industries (Aerospace, Defense, Pharmaceutical, etc.)Ability to work independently and as part of a team; capable of coaching, mentoring, and guiding othersPreferredQuality certifications (e.g., ASQ CQT, QCI)Working knowledge of GMP/ISO standardsEducation & ExperienceHigh school diploma, GED, or equivalent directly transferrable work experienceMinimum 6 years of experience in a regulated manufacturing environment, or equivalent education and experienceCore proficienciesQuality Inspection ExperienceISO 13485Coaching and Mentoring ExperiencePrecision Measurement & Inspection