Working Location: Massachusetts, Westborough; Nationwide

Workplace Flexibility: Remote

Job Description

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.

Job Duties

• 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.

Job Qualifications

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

*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 $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.