Principal Quality Engineer

Working Location: NATIONWIDE

Workplace Flexibility: Remote

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

To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration.

Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to

ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.

Job Duties

• Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and lnternation requirements.

• Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.

• Ensure lntercompany Quality Agreements are established and maintained.

• Manage Notified Body communication and relationship.

• Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner.

• Support the CAPA process.

• Show strong ability to influence without direct authority across functional groups, regions and leadership.

• Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues.

• Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.

• Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.

• Develop innovative and practical solution to complex and unique process problems and system improvement through the use of best practices

• All Other Essential Duties as directed.

Job Qualifications

Required:

• BS degree or equivalent in an engineering or life science discipline.

• Minimum of 8 years' experience working in a highly regulated industry required.

• Demonstrated ability to manage and complete multiple projects and objectives and lead projects with crossfunctional teams.

• Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.

• Experience in audit management, front room and back-room coordination and best practices.

• Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.

• Strong track record of leading and influencing without direct authority.

• Excellent interpersonal, communication (written and oral), presentation and facilitation skills.

• Proficient in most common PC based applications (work, excel, PowerPoint, Project, & Visio).

• Demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

• Will work with global teams, availability will include working across the associated time zones.

Preferred:

• Master's Degree preferred.

• Minimum of 3 years' experience working in an FDA regulated environment preferred.

• Six Sigma Black Belt preferred.

• Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.

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 benefits and incentives: .

The anticipated base pay range for this full-time position is $104,061.00 - $145,685.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.

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 .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

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 [email protected]. 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)