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Principal Quality Engineer, Post Market Surveillance
2 months ago
We are seeking a highly skilled Principal Quality Engineer to lead our Post Market Surveillance efforts globally. As a key member of our team, you will be responsible for executing post market surveillance projects and improvement programs across our global regions.
Key Responsibilities- Contribute to the development and maintenance of global post market surveillance procedures.
- Support and execute initiatives that promote best practices within our Post Market Surveillance Community of Practice.
- Lead project workstreams and post market surveillance improvement programs across global regions.
- Prepare and conduct routine meetings to ensure accountability and milestone achievements with global teams.
- Actively collaborate with internal customers to improve overall outcomes that ensure the safety of products and patients.
- Proactively identify and assess areas of improvement or risk, and escalate issues in a timely manner.
- Support internal and external audits as a subject matter expert.
- Bachelor of Science degree in engineering or technical discipline.
- Minimum of 8 years related experience, preferably in the medical device industry related to operations/design/quality engineering.
- Experience in Post Market Surveillance, including leading or execution of Post Market Surveillance Plans and Periodic Safety Update Reports.
- Knowledge of EU 2017/745 (EU MDR), FDA QSR, ISO 13485, and other applicable industry standards.
- Travel up to 10% of the time domestically or internationally, availability to take evening and early morning teleconferences.
- Proven planning and organizational skills with background and experience in project management principles, practices, techniques, and tools.
- Strong analytical skills and the ability to operate effectively in a team environment.
- Ability to analyze complex problems, interpret operational needs, and develop integrated, creative solutions.
- Must be able to work independently, self-motivated, with a strong sense of ownership and urgency to drive results.
- Responds well under pressure and manages stress.
- Effective at dealing with change and ambiguity as business needs shift, demonstrating flexibility while ensuring compliance.
- Ability to gain cooperation and commitment from people through influence.
- Excellent verbal and written communication skills and comfortable presenting to small and large groups.
- Expert in Excel, Power Point, Visio, and Word.
- Experience in working with global teams.
Olympus Corporation of the Americas is a global medical technology company that partners with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis, and minimally invasive treatment. We are committed to making people's lives healthier, safer, and more fulfilling.
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Our benefits include competitive salaries, annual bonus, 401(k) with company match, comprehensive medical, dental, and vision coverage, and more.
We are dedicated to building a diverse, inclusive, and authentic workplace where our employees can fully contribute and thrive. We recognize diversity in people, views, and lifestyle choices and emphasize the importance of inclusion and mutual respect.
