- Develops quality assurance strategy for sourced products.
- Acts as supplier quality engineering representative in new product development projects.
- Coordinates and ensures the external component qualification/FA process.
- Identifies gaps in suppliers' capabilities / technical project risks.
- Takes decisions on acceptance or rejection of sourced materials.
- Guides inspectors regarding incoming inspections (e.g. training, standards, etc.).
- Leads improvement projects at the supplier.
- Performs material related supplier change management activities.
- Acts as primary interface to supplier regarding product related quality matters.
- Analyzes product related supplier quality issues.
- Is part of the material review board.
- Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP).
- Performs product and process audits at the supplier and initiates appropriate measures, where required.
- Performs Product Qualification Process by applying the appropriate methods.
- Advanced Product Quality Planning (APQP).
- Performs local supplier management such as supplier approval, supplier auditing, QAA negotiation and supplier evaluation if delegated by Supplier Quality Manager (SQM).
- Is specialized in a product group/category and supports the supplier quality engineering team locally and regionally with technical and process knowledge in the category.
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
- Demonstrated expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP
- Knowledge of and minimum 5 years' experience in supplier quality engineering
- High level of quality tools and methodology skills (e.g. 8D, 5-Whys, FMEA, IQ/OQ/PQ, APQP)
- Very good written and oral communication and organizational, project management skills.
- High degree of technical knowledge within the process/category supported
- Very good knowledge of Quality tools and methods ISO 9001 / FDA / Medical technology background.
- High degree of qualification in specific product group.
- Advanced English .
- 20% travel should be expected.
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
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Principal Supplier Quality Engineer - Westborough, United States - Olympus Corporation of the Americas
Description
Working Location: MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
The Principal Supplier Quality Engineer is responsible for the product/service-related supplier quality within defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning. They are specialized in a product group/category and supports the supplier quality engineering team locally and regionally with technical and process knowledge in the category.
Job Duties
Job Qualifications
Required:
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
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.
Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
