Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ? ?
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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
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Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers .
Job Description
Manager, Quality Assurance External Manufacturing is responsible for managing the onboarding manufacturers of sourced finished medical device products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development initiatives.
Job Duties
Supports supplier quality activities for sourced finished Medical Device products and leads these supplier audits in accordance with Olympus global supplier quality processes.
Qualifies sourced finished Medical Device product suppliers by assessing the supplier capabilities through direct on-site visits and technical discussions.
Supports the Olympus Supplier quality team in adding the suppliers onto the approved supplier lists. Prepare Quality Assurance Agreements outlining the roles and responsibilities and relationship between Olympus and the suppliers.
Ensure regulatory and contractual compliance in accordance to FDA, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations.
Develops quality assurance strategy for sourced products including incoming inspection requirements.
Identifies gaps in suppliers' capabilities / technical project risks.
Reviews product specifications, component qualifications, design verification/validations, and process validations.
Leads and participates in Quality Assurance Business Development initiatives within cross-functional teams and captures subject matter expertise within the Business Development function.
Creates and executes Quality Plans for projects such as onboarding new suppliers, product transfers, integration following mergers and acquisitions.
Work with cross-functional teams to support program architecture and ensure effective integration of new suppliers and their products into Olympus' systems.
Ensures functional and regional alignment by coordinating with global and regional QA teams to ensure e?orts are aligned, approvals are maintained, and resources are identified.
Build and maintain a network of resources in all regions, across all businesses and divisions.
Stay current on industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and integration.
Job Qualifications
Required:
Bachelor's degree in a science-related discipline.
Minimum of 8+ years of directly related Quality Assurance experience in the medical device industry.
Knowledge of and experience performing supplier quality audits and involvement in external QMS certi?cation/surveillance audits.
Knowledge of regulators including but not limited to 21CFR820, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations.
Demonstrated ability to work cross-functionally.
Demonstrated ability to lead programs/projects. Has sense of passion, drive and perseverance to accomplish goals.
Excellent team player.
Global understanding of product domains and key technology/therapeutic area/R&D disciplines.
Strong interpersonal skills, including the ability to work across cultures and personality @types.
High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to e?ectively order the unknown.
Excellent communication skills, both verbal and written; ability to quickly distil complex information into actions/recommendations.
Excellent understanding of the typical functional roles and responsibilities of Quality Assurance.
Practical understanding of global regulatory/quality standards and requirements.
Potential for travel up to 30%; domestic and international
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable 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 mindset
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 our team?
Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks .
At Olympus, 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 healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus 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, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, 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 Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let's realize your potential, together.
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 (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related 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, ancestry, 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)
