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Senior Supplier Quality Engineer

4 months ago

Bedford MA, United States InfraredX, Inc. Full time

Responsible for ensuring that Infraredx’s suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Utilize risk-based approach in the classification and management of Infraredx suppliers.
Provide daily support for supplier issues arising at incoming inspection or on manufacturing floor.
Interface with suppliers to obtain quality data and resolve quality issues. Resolution of quality issues to include responsibility of supplier non-conformances, corrective action requests, and CAPA.
Responsible for coordination of initial component quality requirements including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
Maintains supplier quality records in accordance with FDA/GMP and EU MDR requirements.
Coordinate review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
Assist with supplier quarterly evaluation activities (Supplier Performance Scorecard).
Initiate and drive process/yield improvement projects where possible.
Develop and support requirements and activities for “dock-to-stock” program.
Acts as a team member in supporting quality disciplines, decisions, and practices.

Bachelor of Science degree in a technical discipline.
~5-7+ years of quality engineering in life sciences industry, supplier quality experience strongly preferred.
~ Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
~ Proficient with Microsoft Office applications, and willingness to learn Infraredx ERP and PLM systems.
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