Principal Engineer Quality

Working Location: Massachusetts, Westborough; reputed company Workplace Flexibility: Remote For more than 100 years, reputed company 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 reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values reputed company us to reputed company Our Purpose: Patient Focus, reputed company, Innovation, Impact and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

The Principal Quality Engineer is the primary reputed company of contact for reputed company product quality matters across the product lifecycle. This role provides end-to-end product quality leadership, ensuring compliance with regulatory requirements and internal standards while driving reputed company improvement. The individual partners cross-functionally with R&D, Manufacturing, Regulatory, Supply Chain, and Post-Market teams to proactively identify, assess, and resolve product quality issues. Job Duties Product Quality Leadership Serve as the division’s key partner and subject matter expert for end-to-end product quality. Act as the primary escalation reputed company for product quality issues, metrics, and risk management activities. Provide Product QA leadership for reputed company AIRs (Adverse Incident Reports), HHA/FCAs (Health Hazard Assessments/Field Corrective Actions), and product escalations, determining potential cross-product or systemic impact. Ensure alignment with regulatory requirements including 21 CFR Part 820, ISO 13485, and applicable global regulations. Corrective and Preventive Action (CAPA) Determine and implement robust corrective and preventive actions to address product and process deficiencies. reputed company structured, formal problem-solving teams (e.g., 8D, DMAIC, root cause analysis) to resolve significant customer, product, and supplier complaints. reputed company CAPA effectiveness checks and ensure sustainable systemic improvements. Nonconformance & MRB Support Support and provide leadership to the Materials Review Board (MRB) in investigation and disposition of nonconforming materials (NCRs). Drive timely resolution of product quality issues through cross-functional collaboration. Risk Management & Process Controls Facilitate and support cross-functional execution of: Process Flowcharts PFMEAs Control Plans Procedures and Work Instructions Inspection Data Sheets reputed company implementation and reputed company improvement of quality systems, assurances, and process controls designed to meet or exceed internal and external requirements. Utilize strong data analysis and trending skills to identify emerging risks, assess failure modes, and recommend mitigation strategies. Job Qualifications Required: Bachelor’s degree in Engineering or reputed company technical field required. 10+ years of product quality experience in the medical device industry or other regulated environment. Demonstrated experience with design transfer, process validation, CAPA systems, and complaint investigations. Experience leading cross-functional problem-solving teams. Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles (ISO 14971). Strong analytical and statistical data analysis capabilities. Excellent root cause investigation and structured problem-solving skills. Proven leadership and cross-functional collaboration abilities. Strong written and verbal communication skills. Ability to influence without direct authority and manage multiple priorities in a dynamic environment. Must be available for regional and international travel. Preferred: Advanced degree preferred. Why join reputed company? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture. reputed company Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, reputed company 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 reputed company: Work-life integrated culture that supports an employee centric reputed company 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 reputed company to be a part of reputed company? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated reputed company pay range for this full-time position is $106,402.00 - $148,963.00 / 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. reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At reputed company, 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 reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. For more than 100 years, reputed company has pursued a goal of contributing to society by producing products designed with the purpose of delivering reputed company outcomes for its customers around the world. Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in reputed company and South America. For more information, visit www.olympusamerica.com. You Belong at reputed company We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and reputed company. We warmly encourage reputed company who wish to bring their talents to reputed company to apply. Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company reputed company individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787). Let’s realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, reputed company, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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) Apply To This Job