Principal Quality Engineer, Post Market Surveillance - Remote

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

In this role, the Principal Quality Engineer will report to the Director of Post Market Surveillance and will lead the execution of post market surveillance activities within the Olympus Surgical Technologies America (OSTA).

Job Duties

• Plans and executes Post Market Surveillance deliverables such as Post Market Surveillance Plans (PMSP) and Periodic Safety Update Reports (PSUR).
• Escalates quality signals detected as part of PMS activities to appropriate channels, including non-conformance, CAPA, and Health Hazard Analysis.
• Supports investigation of complaint trend signals.
• 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.
• Other essential duties as directed.

Job Qualifications

Required:

• 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%).

Why join Olympus?

 

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

 

Equitable Offerings you can count on:

 

• 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