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Summary
About the Role
About You
- Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline.
- Minimum 5 years of experience in Quality Assurance, Post-Market Surveillance, or Regulatory Affairs within the medical device industry.
- Demonstrated experience leading complaint handling, vigilance reporting, signal detection, and PMS documentation for Class II/III medical devices.
- Strong working knowledge of U.S. and international medical device regulations, including FDA 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC).
- Experience with electronic QMS and complaint handling systems (e.g., TrackWise, Windchill).
- Proficiency in complaint trending and statistical analysis using Excel, Minitab, or other quality tools.
Benefits
- Base salary range of $100k–$120k plus 10% annual bonus.
- Comprehensive benefits package including health insurance and retirement plans.
At Getinge, we are committed to meet today's health care challenges together with health care providers and be part of improving patients’ lives around the globe. Our offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Our journey started in the village of Getinge on the Swedish west coast back in 1904. Today, our operations cover more than 40 countries and we over 10 000 employees. Every single one of us with the firm belief that saving lives is the best job in the world. Learn more about us: https://youtu.be/4FB5vGF78CY Please be aware that LinkedIn is a third-party operated social media site unaffiliated with Getinge. Getinge does not control and is not responsible for the privacy or security policies or practices on this site or any third-party websites that we may link to through this site. We recommend that you carefully review the privacy and security practices of this site and any linked third-party websites. We are not responsible for the accuracy of any information, opinions, claims, or statements posted by our followers or other users of this site. Getinge reserves all rights relating to our account on this site, including, but not limited to, removing postings. While Getinge's product-related advertisement and information is intended to be disseminated only in jurisdictions where the license to market such products has been granted, Getinge has no control over how our posted content is further disseminated through LinkedIn. Therefore, as posts are shared or liked by our followers or other LinkedIn users, we have no control over the geographic reach of such posts, comments, and communications. Please, note the foregoing when reading product-related social media posts and corroborate with local representatives for product licensing.