Principal Quality Engineer - Post Market Surveillance

March 25

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Olympus Corporation of the Americas

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Olympus Corporation of the Americas is a company dedicated to developing and delivering advanced medical technology solutions aimed at enhancing healthcare throughout the patient pathway. Their mission, encapsulated in the philosophy 'True to Life', focuses on improving the standard of care to empower individuals to lead fulfilling lives. Olympus offers a range of medical systems and is also involved in educational programs to support clinical expertise and procedural skills enhancement.

5001 - 10000 employees

🧬 Biotechnology

📋 Description

• Leading post market surveillance activities for Olympus Surgical Technologies America (OSTA). • Plans and executes Post Market Surveillance deliverables such as Post Market Surveillance Plans (PMSP) and Periodic Safety Update Reports (PSUR). • Escalates quality signals detected in post market surveillance activities to appropriate channels. • Supports investigation of complaint trend signals. • Proactively identifies and assesses areas of improvements or risks. • Supports internal and external audits as a subject matter expert.

🎯 Requirements

• Bachelor of Science degree in engineering or technical discipline. • Minimum of 9 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. • 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. Limited travel required. (less than 10%).

🏖️ Benefits

• Competitive salaries, annual bonus and 401(k)* with company match • Comprehensive medical, dental, vision coverage effective on start date • 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**