Senior Supplier Quality Engineer

** Working

Location:

Massachusetts, Westborough;
Nationwide*
* ** Workplace Flexibility:
Hybrid*
* ** _For more than 100 years, Olympus has focused 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 the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

​

Our five Core Values empower us to achieve Our

Purpose:

** Patient Focus, Integrity, Innovation, Impact and Empathy.*
* Learn more about Life at Olympus:
.

** Job Description*
* The 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 Qualifications*
* *
* Required:

*
* + 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…