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    Quality Engineer - Minneapolis, United States - Inspire Medical Systems I

    Inspire Medical Systems I
    Inspire Medical Systems I Minneapolis, United States

    5 days ago

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    Description

    Job Description

    Job Description

    ABOUT INSPIRE MEDICAL SYSTEMS

    Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

    WHY JOIN OUR FAST-GROWING TEAM

    At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

    If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team

    ABOUT THIS POSITION

    This position must provide expertise and leadership in the areas of corrective and preventive action, material controls and warehousing, global quality system requirements, adverse event management, global distributor operations, and process monitoring, trending and reporting. This position will work with Development, Operations, Supply Chain, Marketing, Sales and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.

    OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

    This role may include, but is not limited to the following activities:

    • Lead and coach cross-functional teams to resolve quality issues and navigate the CAPA process.
    • Lead quality activities and manage both the non-conformance and product hold order process for Inspire warehouses and third-party logistics providers (3PLs)
    • Generate product release authorization documentation and lead the PRA process for Inspire.
    • Manage the quality relationship with third party QMS service providers, global product distributors and importers.
    • Lead global monitoring and trending of adverse events for geographic annual reporting and PSUR activities.
    • Coach Inspire personnel on GMP and QMS requirements for medical device manufacturers.
    • Partner with data analyst to develop performance reporting and visualizations on key quality metrics and continuous improvement initiatives for reporting.
    • Lead special projects along with product improvement processes at the direction of quality management.
    • Support and participate in QMS audits with both internal and external auditors as a subject matter expert.
    • Lead and/or participate in supplier audits for service providers or other vendors as assigned.
    • Approve DHRs, DHF deliverables, product releases, CAPAs, SCRs and ECOs.
    • Conduct first article inspections (FAIs) on finished medical products and medical device labeling.
    • Support internal labeling reviews to ensure required markings and symbols are present.
    • Manage translation activities with translation partner to ensure translations and required files are delivered to development for ECO.
    • Support in-house product repairs, special build requests and part-time staff (college interns).

    Required Qualifications

    • Bachelor's degree in a technical or scientific field.
    • 5 - 10 years minimum experience in quality or design function in the finished medical device industry
    • Demonstrated team leadership skills and ability to prioritize, execute and report on projects
    • Experience with Class III active implantables
    • Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
    • 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 of MS Word, Excel and PowerPoint

    Preferred Qualifications

    • Bachelor's degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.
    • Master's degree in a technical or scientific field.
    • Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
    • Experience with GHTF requirements for process validations, etc.
    • Experience in design reliability, process and product quality assurance functions
    • ISO 13485 certified auditor or RAB auditor
    • ASQ certifications; CRE, CQM, CQE, CQA etc.

    Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

    Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email (dot)com

    Inspire Medical Systems participates in E-Verify.

    #LI-AM1

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