Quality Engineer - Case Review
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 ISO14971
- 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.
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