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**Senior Product Quality Engineer**

2 months ago

Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
About Inspire Medical Systems

We are a pioneering medical device company dedicated to revolutionizing the sleep industry with our innovative FDA-approved device. Our mission is to make a meaningful difference in the lives of those living with Obstructive Sleep Apnea (OSA). We prioritize patient outcomes and foster a culture of collaboration, learning, and growth.

Why Work with Us

We value diversity, equity, and inclusion, and strive to create a workplace where everyone feels welcome and empowered to contribute. Our benefits package includes hybrid work schedules, excellent compensation, 401k matching, ESPP, flexible time off, and tuition reimbursement.

About the Role

This is a critical position that requires expertise in finished medical device manufacturing, product inspection/test, manufacturing process monitoring and control implementation, sterilization, labeling, supplier development, audit, and supplier management. The successful candidate will work closely with cross-functional teams to ensure regulatory compliance and product reliability.

Key Responsibilities
  • Partner with the manufacturing team to lead/support quality engineering activities with contract manufacturers.
  • Manage non-conformance, deviation, and temporary authorization processes for contract manufacturers and Inspire.
  • Lead and coach cross-functional teams to resolve quality issues and navigate the CAPA process.
  • Coach personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.
  • Conduct first article inspections (FAIs) on finished medical products.
  • Provide expertise on finished device specifications and generate and approve ECOs.
  • Generate and approve design history file documents, device master record documents, and supplier change request records.
  • Lead IP development processes for warehouse inspections of new products and revise existing IPs for contract manufacturers as needed.
  • Lead contract manufacturer (supplier) audits.
  • Support manufacturing risk management activities (i.e., pFMEA) at suppliers.
  • Lead special projects (e.g., dual sourcing, metrics, etc.) and supplier product improvement processes at the direction of quality management.
  • Participate in product performance reviews and emerging quality reviews; support any resulting corrective/preventive actions.
  • Support QMS audits with both internal and external auditors.
  • Ability to work efficiently and effectively in both a paper-based and electronic QMS.
  • Recommend process improvements, driving both efficiency and compliance.
Requirements
  • Bachelor's degree in a technical or scientific field, preferably an engineering discipline.
  • 5 years minimum experience in medical device manufacturing.
  • 5 years minimum experience in a product, manufacturing quality (process), material, or component quality engineering position.
  • Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; FDA 21 CFR Part 820).
  • Demonstrated team leadership skills and ability to prioritize, execute, and report on projects.
  • Experience with engineering tools such as; dFMEA, pFMEA, SPC, etc.
  • Working knowledge of process improvement techniques such as Six Sigma, Lean Sigma, Proof of Station, etc.
  • Strong project and time management skills.
  • Demonstrated creative and effective problem-solving and original thinking for compliance solutions.
  • Ability to work on multiple tasks concurrently with changing priorities.
  • Proficient with MS Word, Excel, and PowerPoint.
Preferred Qualifications
  • Master's degree in a technical or scientific field.
  • Experience in component, manufacturing quality (process), and product quality assurance functions.
  • Experience in design assurance or quality systems functions.
  • Experience with 21 CFR 820, ISO 13485, ISO 14971, European Directives, and European Regulations.
  • Experience with SPC software tools.
  • Experience with engineering tools such as; DOE, FTA, GHTF requirements for process validations, etc.
  • ISO 13485 certified auditor or RAB auditor.
  • ASQ certifications; CRE, CQM, CQE, CQA, etc.
  • ISO 14971 training.