Working Location: Massachusetts, Westborough; Nationwide Workplace Flexibility: HybridJob DescriptionThe Senior Supplier Quality Engineer is responsible for the product-related supplier quality within a 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 and SCN handling.
Job Duties- Develops quality assurance strategy for sourced products including suppliers and incoming inspection in cooperation with Manufacturing Quality Assurance.
- Acts as a supplier quality engineering representative in new product development projects.
- Performs Advanced Product Quality Planning (APQP) by applying the appropriate methods including early supplier involvement in development projects and assures that required process validations are sufficiently implemented through the External Product Qualification process.
- Coordinates and ensures the external component qualification/FAI process is effective.
- Identifies gaps in suppliers' capabilities / technical project risks.
- Accountable for and manages Supplier Change Notification (SCN) process for sourced materials by closely and proactively working with Procurement and other cross-functional areas as necessary for timely assessment, documentation and disposition of supplier requested changes.
- Accountable for incoming inspection planning for sourced materials, and makes decisions on acceptance or rejection in collaboration with receiving site.
- Guides inspectors regarding incoming inspections (e.g. training, standards, etc.).
- Supports site-level Material Review Boards for timely disposition of non-conforming material by owning or supporting NC Records.
- Accountable for Supplier Corrective Action Request (SCAR) as part of the NC management process by working with supplier for timely resolution of identified non-conformity and prevention of potential non-conformity through verification of effectiveness.
- Leads improvement projects at the supplier.
- Acts as primary interface to supplier regarding product-related quality matters.
- Analyzes product related supplier quality issues.
- Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP).
- Supports Supplier audits as co-auditor.
- Performs local supplier management such as supplier approval, supplier auditing, QAA negotiation and supplier evaluation if delegated by SQM.
Job QualificationsRequired:- Should have experience on fiber optic laser system manufacturing preferably in medical device or related Industry.
- Hands on experience on system-level manufacturing processes, production equivalence verification & validation and understanding of traceability of production back to requirements in the DHF.
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
- Knowledge of and minimum 5 years' experience in supplier quality engineering.
- Very good knowledge of Quality tools and methods.
- ISO 9001 / 13485/ FDA / Medical technology background.
- Qualification in specific product group.
- Basic project management skills.
- Advanced English.
- 20% travel should be expected.
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.
The anticipated base pay range for this full-time position in this location is $98,056.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
