Working Location: NATIONWIDE

Workplace Flexibility: Hybrid

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 (https://www.olympusamerica.com/careers) .

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

The Principal Quality Engineer, Complaint Management Compliance is an experienced professional with wide-ranging experience and expertise in CAPA to ensure regulatory compliance and patient safety

Job Duties

• Lead and oversee the Complaints Global CAPAs, ensuring timely identification, investigation, and resolution of quality issues.

• Follow global CAPA procedures and guidelines in alignment with regulatory requirements.

• Provide training to staff on CAPA processes, quality systems, and regulatory requirements.

• Serve as a subject matter expert on quality engineering practices and compliance.

• Conduct thorough investigations to determine root causes of quality issues and non-conformances.

• Utilize various problem-solving methodologies (e.g., Fishbone diagrams, 5 Whys, etc.) to facilitate effective analysis.

• Perform risk assessments related to identified CAPAs and develop mitigation plans.

• Collaborate with cross-functional teams to assess the impact of quality issues on product safety and effectiveness.

• Ensure proper documentation of CAPA activities, including investigation reports, corrective action plans, and effectiveness checks.

• Prepare and present CAPA reports to management and regulatory bodies as needed.

• Work closely with other departments, such as R&D, Manufacturing, and Regulatory Affairs, to ensure alignment on quality objectives.

Job Qualifications

Required:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.

• A minimum of 10 years of experience in quality engineering, quality assurance, or regulatory compliance within a relevant industry (e.g., medical devices, pharmaceuticals).

• A minimum of 5 years of experience in CAPA.

• Strong knowledge of quality management systems (QMS) and regulatory standards (e.g., ISO 13485, FDA regulations).

• Travel up to 20% of the time domestically or internationally, availability to take evening and early morning teleconferences.

Preferred:

• Analytical Skills: Strong ability to analyze data, identify trends, and perform root cause analysis using various methodologies.

• Problem-Solving: Proficient in developing and implementing corrective and preventive actions to address quality issues.

• Regulatory Knowledge: Familiarity with industry regulations and standards (e.g., FDA, ISO, GMP) to ensure compliance in all CAPA activities.

• Project Management: Skills in managing multiple CAPA projects, including planning, execution, and follow-up, to ensure timely resolution of issues.

• Communication: Excellent verbal and written communication skills for effectively conveying information to cross-functional teams and documenting findings.

• Collaboration: Ability to work effectively with diverse teams, fostering collaboration among engineering, production, quality assurance, and regulatory affairs.

• Attention to Detail: A keen eye for detail to ensure thorough investigations and accurate documentation.

• Technical Knowledge: Understanding of the product lifecycle and engineering principles relevant to the industry.

• Training and Mentoring: Skills in training others on CAPA processes and fostering a culture of quality within the organization.

• Continuous Improvement Mindset: Commitment to identifying opportunities for process enhancements and promoting a proactive approach to quality management.

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

• Diversity Equity & Inclusion Initiatives including 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 (https://www.olympusamerica.com/careers/benefits-perks) .

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 .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

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.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).

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