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. #J-18808-Ljbffr

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