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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 post implant case review, device performance monitoring, therapy support and the post implant care pathway as well as post market monitoring and reporting. This position will work cross-functionally to troubleshoot both therapy and system performance issues. In addition, this role will ensure case review and post market surveillance activities are completed in accordance with Inspire procedures and geographic regulations. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE Lead bi-weekly post implant case review team meetings and maintain tracking documentation. Provide expertise on implanted system troubleshooting and therapy performance issues. Create formal recommendation letters for healthcare providers as it relates to system performance. Engage with field teams to obtain necessary diagnostic data for troubleshooting and drive case resolution. Update complaint handling files (product reports) as required. Query case review tracking database and complaint handling system to obtain performance monitoring data Support data requests for regulatory review process as it relates to post market data and data analysis. Participate / lead quarterly surgical training quality reviews by compiling, analyzing and presenting data to the surgical training team Create and approve both quality and quality system records Assist in product reporting process (complaint handling) as assigned, for all Inspire products. This may include the initial evaluation, risk evaluation, root cause determination, CAPA evaluation and product report closure. Support cross-functional teams to resolve quality issues and complete CAPAs. Support QMS audits with both internal and external auditors Support PMS team projects Required Qualifications Bachelor's degree in a technical or scientific field. 5 - 10 years minimum experience in quality, quality operations, design reliability or design assurance function in the finished medical device industry Demonstrated team leadership skills and ability to prioritize, execute and report on projects Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822) Excellent communication skills, both oral and written, along with the ability to communicate effectively with all levels in the company Experience in post market surveillance quality monitoring and reporting Strong project and time management skills 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, or Biomedical. Master's degree in a technical or scientific field Experience in sleep science or sleep related therapies. Experience with Class III active implantables Experience with risk management standard ISO14 71 Experience with risk management tools such as; dFMEA and pFMEA ISO 13485 certified auditor ASQ certifications; CRE, CQM, CQE, CQA etc. Physical Requirements: Ability to lift 30 lbs. 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 anequal opportunityemployer 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 844-672-4357 or email careers@inspiresleep(dot)com Inspire Medical Systems participates in E-Verify. #LI-AM1 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 with regard to 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 are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep.com.