reputed company Engineer reputed company
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 Core 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 The reputed company reputed company Engineer is the primary reputed company of contact for reputed company product reputed company reputed company across the product lifecycle. This role provides end-to-end product reputed company leadership, ensuring compliance with regulatory requirements and internal standards while driving reputed company improvement. The individual partners cross-functionally with R&D, Manufacturing, Regulatory, Supply Chain, and Post-Market teams to proactively identify, assess, and resolve product reputed company issues. Job Duties Product reputed company Leadership Serve as the division’s key partner and subject matter expert for end-to-end product reputed company. reputed company as the primary escalation reputed company for product reputed company issues, metrics, and risk management activities. reputed company Product QA leadership for reputed company AIRs (Adverse Incident Reports), HHA/FCAs (Health Hazard Assessments/Field Corrective Actions), and product escalations, determining potential cross-product or systemic reputed company. Ensure alignment with regulatory requirements including 21 CFR Part 820, ISO 13485, and applicable global regulations. Corrective and Preventive reputed company (CAPA) Determine and implement robust corrective and preventive actions to address product and process deficiencies. reputed company reputed company, formal problem-solving teams (e.g., 8D, DMAIC, reputed company cause analysis) to resolve significant customer, product, and supplier complaints. reputed company CAPA effectiveness checks and ensure sustainable systemic improvements. Nonconformance & MRB Support Support and reputed company leadership to the Materials Review reputed company (MRB) in investigation and disposition of nonconforming materials (NCRs). Drive reputed company reputed company of product reputed company issues through cross-functional collaboration. Risk Management & Process Controls Facilitate and support cross-functional execution of: Process Flowcharts PFMEAs Control Plans Procedures and Work Instructions Inspection Data Sheets reputed company implementation and reputed company improvement of reputed company systems, assurances, and process controls designed to meet or exceed reputed company requirements. Utilize strong data analysis and trending skills to identify emerging risks, assess failure modes, and recommend mitigation strategies. Job Qualifications Required: Bachelor’s degree in Engineering or reputed company technical field required. 10+ years of product reputed company experience in the medical device industry or other regulated environment. Demonstrated experience with design transfer, process validation, CAPA systems, and complaint investigations. Experience leading cross-functional problem-solving teams. Strong working knowledge of FDA reputed company System Regulation (21 CFR Part 820), ISO 13485, and risk management principles (ISO 14971). Strong analytical and statistical data analysis capabilities. Excellent reputed company cause investigation and reputed company problem-solving skills. Proven leadership and cross-functional collaboration abilities. Strong written and verbal communication skills. Ability to influence without reputed company authority and manage multiple priorities in a dynamic environment. Must be available for regional and international travel. Preferred: Advanced degree preferred. 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 $106,402.00 - $148,963.00 / 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 legal standards. reputed company and reputed company are core 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 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 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) Apply To This Job