Director, Manufacturing Quality, GIS (Japan Based)

Req ID: 10579 Working Location: Massachusetts, Westborough; reputed company Workplace Flexibility: Remote For more than 100 years, reputed company 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 reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values reputed company us to reputed company Our Purpose: Patient Focus, reputed company, Innovation, Impact and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

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 reputed company improvement reputed company 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 reputed company 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.
• reputed company 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.
• reputed company 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.
• reputed company 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.
• reputed company 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 reputed company? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture. reputed company 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 reputed company
• 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 reputed company? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated reputed company 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. reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At reputed company, 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 reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. For more than 100 years, reputed company 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, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, 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 reputed company We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage reputed company who wish to bring their talents to reputed company to apply. Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company qualified individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787). Let’s realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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) Job reputed company: Quality Manager, QA, Quality Assurance, Geology, GIS, Quality, Technology, Engineering Apply tot his job Apply To this Job