Working Location: Massachusetts, Westborough; 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: https://www.olympusamerica.com/careers.
This position is located at the Aizu Manufacturing Location in Japan and requires the leader to be onsite 5 days a week. The Director, Manufacturing Quality, GIS is responsible for providing strategic leadership at the site and directs execution of the Quality System to ensure compliance with regulatory requirements while supporting business strategy. Serves as the site Quality Leader and Management Representative, ensuring the Quality Management System (QMS) is effectively implemented and maintained. Leads quality support for new product development, procurement, manufacturing, returns, and servicing activities. Acts as a subject matter expert in Quality Engineering and regulatory compliance. Drives cross-site quality initiatives and continuous improvement aligned with corporate objectives. Builds and ensures effective relationship with senior leader responsible for manufacturing, R&D, etc. Understands business needs and is proactive in addressing quality issues across multiple product lines.
- Manage and lead the site Quality organization supporting NPD, procurement, manufacturing, servicing, and returns.
- Ensure Quality System compliance with FDA QSR, ISO 13485, MDR, Canadian Medical Device Regulations, and other applicable standards.
- Serve as Management Representative and ensure Management Reviews are conducted per policy.
- Oversee CAPA system effectiveness including investigation, root cause analysis, validation, and implementation.
- Manage complaint handling to ensure timely investigation and customer response.
- Ensure control and proper disposition of nonconforming product.
- Oversee Quality System documentation including DHF, DMR, DHR, labeling, and change management.
- Ensure validation and verification strategies for new and existing products and processes are robust and compliant.
- Lead internal, supplier, and regulatory audits and host external inspections (FDA, ISO, etc.).
- Monitor performance metrics and drive measurable improvements in compliance, product quality, and process performance.
- Develop and manage departmental budget and resources.
- Communicate significant quality risks to site and corporate leadership and ensure corrective action plans are implemented.
Required:
- Bachelor’s degree or equivalent required.
- Minimum of 10 years of Quality experience, preferably in the medical device industry. Demonstrated experience leading Quality Systems in regulated environments and managing regulatory inspections.
- Knowledge of FDA QSR, ISO 13485, MDR, Canadian Medical Device Regulations; strong analytical and statistical skills; proven leadership capability; ASQ certification preferred.
- POSITION LOCATED AT THE: Aizu Manufacturing Location in Japan so you must be willing to relocate to Japan for a 2-3 year assignment
- Travel up to 10% as required
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
**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 $134,666.00 - $188,532.00 / 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)
