Quality Engineer (in office – Traverse City, MI)
Thompson Retractor has an opportunity for a Product Quality Engineer. The Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes that ensure medical devices meet applicable regulatory requirements and customer expectations. This role serves as a key technical resource for inspection planning, measurement system validation, customer complaint management, and regulatory document impact assessments. The Quality Engineer will work cross-functionally with manufacturing, engineering, and regulatory affairs to uphold compliance with 21 CFR Part 820, ISO 13485:2016, and the EU Medical Device Regulation (EU MDR 2017/745).
Thompson is employee-owned and vested employees automatically receive company shares.
What you’ll do:
- Develop, author, and maintain internal Quality Inspection Plans (QIPs) for machined components and assemblies, including critical-to-quality (CTQ) characteristic identification.
- Lead end-to-end APQP phases for new program launches, tracking milestones to ensure compliance with customer specifications. Compile and submit complete PPAP packages- including PFMEA, Control Plans, MSA, and dimensional results—securing on-time customer sign-offs.
- Collaborate with manufacturing and process engineers to ensure inspection plans reflect current production processes, drawing revisions, and design intent.
- Perform initial process studies (SPC) and capability analysis to verify manufacturing process stability prior to customer submission.
- Review and interpret engineering drawings, GD&T (ASME Y14.5), material specifications, and customer requirements to establish dimensional and functional acceptance criteria.
- Collaborate with the CMM Programmer to capture, document, and maintain Coordinate Measuring Machine (CMM) set-up plans, including part datum alignment, fixturing requirements, probe configurations, and reference feature sequences.
- Translate CMM Programmer inputs into clear, controlled set-up documentation (work instructions, setup sheets, and visual aids) that inspection personnel can consistently execute on the shop floor.
- Serve as the primary Quality point of contact for the intake, processing, and closure of customer complaints in accordance with 21 CFR Part 820.198 and ISO 13485 Section 8.2.2.
- Manage the end-to-end complaint lifecycle: receipt and acknowledgment, initial evaluation, complaint investigation, root cause analysis, corrective action, and formal closure.
- Collaborate with the Risk Manager and Regulatory Affairs to evaluate each complaint for adverse event and MDR/Vigilance reportability; provide quality investigation findings, device history records, and risk data to support the reportability determination; ensure timely submission of Medical Device Reports (MDRs) to FDA and Vigilance Reports to Notified Bodies / Competent Authorities.
- Lead and document formal impact assessments when external regulatory standards, guidance documents, or customer specifications are revised or newly issued.
- Review regulatory updates for applicability to current products, processes, quality management system (QMS) procedures, and technical documentation; identify gaps and compliance risks.
- Support the update or creation of quality system procedures, work instructions, forms, and technical file content to reflect regulatory changes; ensure document control compliance throughout.
- Participate in internal and external audits (FDA inspections, ISO 13485 certification audits, Notified Body audits); prepare audit-ready documentation and serve as Subject Matter Expert for inspection planning, complaint management, and QMS sections.
This Might Describe You:
- Bachelor’s or equivalence in Science, Engineering, or relative technical field, min. 5 + years previous quality / regulatory experience, and basic knowledge of ISO, FDA, and EU standards.
- Strong working knowledge of 21 CFR Part 820 Quality System Regulation (and awareness of FDA Quality Management System Regulation transition)
- Practical experience with ISO 13485:2016 QMS requirements and implementation
- Understanding of EU MDR 2017/745 requirements, including UDI, PMS, Vigilance, and Technical File obligations; familiarity with adverse event reportability criteria applied in collaboration with Risk Management and Regulatory Affairs
- Familiarity with MDR/Vigilance reporting criteria; ability to support reportability determinations by providing quality data and investigation findings to Risk Manager and Regulatory Affairs
- Ability to read and interpret CMM set-up plans and measurement reports; experience collaborating with CMM Programmers to capture and document set-up requirements
- Experience with quality tools: FMEA, 8D, Control Plans, PPAP/FAI, SPC, MSA/GR&R
- Familiarity with machining processes (CNC milling, turning, grinding) and their quality characteristics
EEO/AA
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Retirement plan
- Vision insurance
Work Location: In person
