Quality Systems Manager

Req ID: 10859 Working Location: Nationwide; Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley 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: https://www.olympusamerica.com/careers . Job Description This role is responsible for leading and maintaining an integrated Quality Management System (QMS) framework for Document Control, Records Management, and Training across the organization. This role ensures compliance with applicable regulatory requirements, industry standards, and internal quality system procedures while driving harmonization, continuous improvement, and operational excellence. This position provides strategic and operational leadership for document and record control processes, QMS training programs, learning management systems (LMS), and organizational training effectiveness. The position partners closely with Quality, Regulatory Affairs, Operations, Engineering, Supply Chain, Human Resources, Information Technology, and other functional groups to ensure that employees are appropriately trained and that controlled quality documents and records are managed throughout their lifecycle. The role serves as a key leader within the Quality Systems organization, supporting inspection readiness, change management, global harmonization initiatives, and the ongoing effectiveness of the Quality Management System. Job Duties Lead and manage Document Control Management personnel to ensure effective execution of document lifecycle activities, including creation, review, approval, issuance, revision, archival, and retention of controlled documents and quality records. Manage training specialists responsible for curriculum development, training delivery, and training compliance monitoring. Oversee the lifecycle management of controlled documents, quality records, change control activities, and training records to ensure accuracy, integrity, and inspection readiness. Serve as the Quality Systems focal point for document, change control and training processes, establishing priorities and ensuring timely implementation of changes and deployment of training. Partner with cross-functional teams (Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and other business functions) to support quality system changes, product lifecycle activities, and organizational initiatives. Establish and monitor performance metrics for document control, training compliance, and quality system effectiveness, driving continuous improvement and operational excellence. Provide leadership, coaching, and development to Document Control and Training personnel, ensuring effective execution of departmental objectives and strategic priorities. Support regulatory inspections, internal and external audits, CAPA activities, and quality system harmonization initiatives by ensuring compliant documentation and training processes. Lead implementation of quality system improvements, training effectiveness initiatives, and process standardization efforts that enhance compliance, efficiency, and employee performance. Support CAPA, audit, management review, and compliance activities related to documentation and training processes. Job Requirements Required: Bachelor's degree required in Engineering, Life Sciences, Quality, Technical Discipline, Education, Organizational Development, Business, or related field. Minimum of 7 years of experience required in Quality Systems, Document Control, Training Management, or related regulated industry functions. Experience supporting FDA-regulated and/or ISO-certified environments. Experience with Document Management Systems (DMS), Electronic Quality Management Systems, Learning Management Systems (LMS), and Change Control systems. Experience leading cross-functional projects and organizational change initiatives. Thorough knowledge of FDA Quality System Regulations, ISO 13485, and applicable global regulatory requirements. Strong understanding of quality systems, document control, training management, and change control processes. Demonstrated ability to develop, implement, and improve quality system processes and training programs. Strong project management, problem-solving, and organizational skills. Ability to manage multiple priorities and influence cross-functional stakeholders. Excellent verbal, written, and presentation skills. Strong analytical and metrics-driven decision-making capabilities. Ability to build collaborative relationships across all organizational levels. Proficiency with Microsoft Office applications, electronic document management systems, ERP systems, and Learning Management Systems. Demonstrated commitment to continuous improvement, compliance, and operational excellence. May require periodic travel (up to 10–20%) domestic to support multiple sites, audits, training activities, and business initiatives. Acts as a key contributor to inspection readiness and quality culture development throughout the organization. Preferred: Minimum of 5 years of progressive leadership or people management experience preferred. Experience with global quality system harmonization and quality system integration projects 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: https://www.olympusamerica.com/careers/benefits-perks . The anticipated base 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. 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 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) Job Segment: Quality Manager, Document Control, QA, Quality Assurance, PLM, Quality, Administrative, Technology, Management