Director, Medical Device Quality — Japan Relocation

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

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.