Director, Manufacturing Quality, GIS (Japan Based)

Olympus Corporation; Center Valley (Lehigh County); On-site; USD 134,666 - 188,532; Full time

Benefits offered by this job

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

Paid Vacation and Sick Time

Paid Parental Leave

On-Site Child Daycare

Job summary

Olympus Corporation is seeking a Director, Manufacturing Quality for its Aizu location in Japan. This role will lead the Quality organization, ensuring compliance with FDA QSR, ISO 13485, and similar standards, while managing effective CAPA systems and complaint handling. Candidates must possess at least 10 years of relevant quality experience in the medical device industry, along with a Bachelor's degree. The position requires relocation to Japan for a 2–3 year assignment and offers competitive salaries with potential bonuses and benefits.

Qualifications

• Minimum of 10 years of Quality experience, especially in the medical device industry.
• Experience leading Quality Systems and managing regulatory inspections.
• Relocation to Japan for a 2–3 year assignment required.

Responsibilities

• Manage and lead the site Quality organization for various processes.
• Ensure compliance with FDA QSR, ISO 13485, and other standards.
• Oversee effectiveness of CAPA system.
• Manage complaint handling and nonconforming products.

Skills

Quality Systems in regulated environments

Analytical and statistical skills

Leadership capability

Knowledge of FDA QSR

Knowledge of ISO 13485

Knowledge of MDR

Knowledge of Canadian Medical Device Regulations

Education

Bachelor’s degree or equivalent

Tools

ASQ certification

Job description

Director, Manufacturing Quality, GIS

Location: Aizu Manufacturing Location, Japan (relocation required)

Responsibilities

• 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.

Qualifications

• 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; relocation to Japan for a 2–3 year assignment required.
• Travel up to 10% as required.

Benefits and Compensation

Base pay range: $134,666.00 – $188,532.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements).

• 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**

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, citizenship status, religious creed, age, sex, gender identity and expression, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.