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Principal Quality Engineer, Post Market Surveillance
2 months ago
We are seeking a highly skilled Principal Quality Engineer to join our team in Post Market Surveillance. This role will report to the Director of Post Market Surveillance and will lead the execution of post market surveillance projects and improvement programs across the global regions.
Key Responsibilities- Contribute to the development and maintenance of global post market surveillance procedures.
- Supports, plans, and executes initiatives that support the Post Market Surveillance Community of Practice for Olympus globally.
- Leads project workstreams and post market surveillance improvement programs across the global regions.
- Prepare, conduct, and support routine meetings to ensure accountability and milestone achievements with global teams.
- Actively seeks collaboration and builds relationships with internal customers to improve overall outcomes that ensure the safety of products and patients.
- Proactively identify and assess areas of improvements or risks and escalates 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, a sense of ownership with a strong sense of urgency to drive for 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.
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, and 401(k) with company match, comprehensive medical, dental, vision coverage, 24/7 Employee Assistance Program, free live and on-demand Wellbeing Programs, generous Paid Vacation and Sick Time, Paid Parental Leave and Adoption Assistance, 12 Paid Holidays, On-Site Child Daycare, Café, Fitness Center, and more.
We are committed to building a diverse, inclusive, and authentic workplace where our employees can fully contribute and thrive.
