Principal Quality Engineer

Job Duties

• Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and international 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 intercompany 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) and 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.
• Provide expertise in the application of Quality sciences including data analysis, problem solving and creation of system solutions for Quality System issues.
• 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 solutions to complex and unique process problems and system improvement through best practices.
• All other essential duties as directed.

Required:

• BS degree or equivalent in an engineering or life science discipline.
• Minimum of 8 years' experience working in a highly regulated industry.
• Demonstrated ability to manage and complete multiple projects and objectives and lead projects with cross‑functional 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 (Word, Excel, PowerPoint, Project, & Visio).
• Demonstrate the highest ethical standards, actively promote 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.
• Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.

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

• Competitive salaries, annual bonus and 401(k) with company match.
• 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.

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.