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Senior Quality Assurance Engineer

4 weeks ago

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

At Inspire Medical Systems, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the highest level of product reliability and regulatory compliance.

Key Responsibilities:

  • Provide expertise and leadership in finished medical device manufacturing, product inspection/test, manufacturing process monitoring and control implementation, sterilization, labeling, supplier development, audit and supplier management.
  • Work with Development, Operations, Manufacturing, Regulatory and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations.
  • Manage non-conformance, deviation, and temporary authorization processes for both contract manufacturers and Inspire.
  • Lead cross-functional teams with contract manufacturers to resolve quality issues and navigate the CAPA process.
  • Coach Inspire personnel and contract manufacturers on GMP and QMS requirements for medical device manufacturers.

Requirements:

  • Bachelor's degree in a technical or scientific field, preferably an engineering discipline.
  • 5 years minimum experience in medical device manufacturing and quality assurance.
  • 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.

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.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.

Equal Employment Opportunity:

Inspire Medical Systems is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment.