Principal Quality Engineer, Post Market Surveillance - Remote

Req ID: 9561

Working Location: NATIONWIDE

Workplace Flexibility: Field

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

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.

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
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $111,675.00 - $156,345.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Job Segment: Quality Engineer, Medical Device Engineer, Project Manager, QA, Engineer, Engineering, Technology, Quality

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