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Inspire Medical Systems · 2 days ago
Quality Engineer - Case Review
Golden Valley, MN
Full-time
Hybrid
Senior Level
5+ years exp
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Responsibilities
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.
Qualification
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Required
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 MS Word, Excel and PowerPoint
Preferred
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.
Benefits
401k matching
ESPP
Flexible Time Off (FTO)
Tuition Reimbursement
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1,001-5,000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (1)
2022 (3)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Amzak Capital ManagementOrbiMedMedtronic
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO· nyse:INSP
Leadership Team
Tim Herbert
President & CEO
Philip J. Ebeling
Chief Operating Officer
Recent News
2024-05-08
Medical Product Outsourcing
2024-04-03
Company data provided by crunchbase
