Senior Supplier Quality Engineer - Medical Devices (Hybrid)

Olympus America, Inc.; Brooklyn Park (MN); Hybrid; USD 98,000 - 135,000; Full time

Job summary

Olympus America, Inc. in Westborough, MA is seeking a Senior Supplier Quality Engineer to own product-related supplier quality within a defined material segment and site, including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling, and incoming inspection planning and SCN handling.

Required: fiber optic laser system manufacturing experience, 5+ years supplier quality engineering, ISO 9001/13485/FDA background, advanced

Qualifications

• BA/BS degree or equivalent in Life Science, Engineering, or Physical Science with an advanced technical degree.
• Minimum 5 years’ experience in supplier quality engineering.
• Knowledge of Quality tools and methods.
• ISO 9001 / 13485/ FDA / Medical technology background.
• 20% travel should be expected.

Responsibilities

• 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.
• 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.

Skills

Fiber optic laser

System-level manufacturing

Advanced English

Travel 20%

Education

BA/BS degree or equivalent in Life Science, Engineering, or Physical Science with an advanced technical degree

Tools

Quality tools & methods

ISO 9001 / 13485 / FDA background

Job description

Olympus America, Inc. in Westborough, MA is seeking a Senior Supplier Quality Engineer to own product-related supplier quality within a defined material segment and site, including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling, and incoming inspection planning and SCN handling.

Required: fiber optic laser system manufacturing experience, 5+ years supplier quality engineering, ISO 9001/13485/FDA background, advanced