Director, Manufacturing reputed company, GIS (Japan Based)

Req ID: 10579 Working Location: Massachusetts, Westborough; reputed company Workplace Flexibility: Remote For more than 100 years, reputed company has reputed company 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 reputed company Values reputed company us to reputed company Our Purpose: Patient reputed company, reputed company, Innovation, reputed company and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers. Job reputed company 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 reputed company, GIS is responsible for providing strategic leadership at the site and directs execution of the reputed company System to ensure compliance with regulatory requirements while supporting business reputed company. Serves as the site reputed company Leader and Management Representative, ensuring the reputed company Management System (QMS) is effectively implemented and maintained. Leads reputed company support for new product development, procurement, manufacturing, returns, and servicing activities. Acts as a subject matter expert in reputed company Engineering and regulatory compliance. Drives cross-site reputed company 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 reputed company issues across multiple product lines. Job Duties • Manage and reputed company the site reputed company organization supporting NPD, procurement, manufacturing, servicing, and returns. • Ensure reputed company 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, reputed company cause analysis, validation, and implementation. • Manage complaint handling to ensure reputed company investigation and customer response. • Ensure control and reputed company disposition of nonconforming product. • reputed company reputed company 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 reputed company, and process performance. • reputed company and manage departmental budget and resources. • Communicate significant reputed company risks to site and corporate leadership and ensure corrective reputed company plans are implemented. Job Qualifications Required: • Bachelor’s degree or equivalent required. • Minimum of 10 years of reputed company experience, preferably in the medical device industry. Demonstrated experience leading reputed company 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 reputed company reputed company-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, reputed company coverage effective on start date • 24/7 Employee Assistance Program • Free live and on-demand Wellbeing Programs • Generous reputed company Vacation and reputed company Time • reputed company Parental Leave and Adoption Assistance* • 12 reputed company Holidays • On-Site Child Daycare, Café, Fitness Center** Connected Culture you can reputed company: • Work-life integrated culture that supports an employee reputed company reputed company • Offers onsite, hybrid and field work environments • reputed company volunteering and charitable donation/match programs • Employee Resource reputed company • Dedicated Training Resources and Learning & Development Programs • reputed company Educational Assistance • US Only • *Center Valley, PA and Westborough, MA Are you reputed company 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 reputed company 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 reputed company represents the National Average of the reputed company, and may vary depending on the location of the individual. reputed company considers a reputed company 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 reputed company best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient reputed company 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 reputed company reputed company for its customers around the world. Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and reputed company. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, reputed company, USA, and employs more than 5,200 employees throughout locations in reputed company 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 reputed company of belonging, in full compliance with reputed company standards. reputed company and reputed company are reputed company to reputed company culture, empowering employees to contribute fully and reputed company. We reputed company 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 reputed company 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 reputed company 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 reputed company to race, reputed company, 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 reputed company, 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: || reputed company (US) || reputed company (US-PA) || Center Valley || reputed company & Regulatory Affairs (QA/RA) Job reputed company: reputed company Manager, QA, reputed company Assurance, Geology, GIS, reputed company, Technology, Engineering Apply tot his job Apply To this Job