Senior Supplier Quality Engineer
Company: InfraredX, Inc.
Location: Bedford
Posted on: May 18, 2024
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Job Description:
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. Key team
member providing expertise on the capability of our suppliers, in
establishing and maintaining the technical activities of our
suppliers, and ensuring they meet business needs. Key
Responsibilities: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.Participate in qualification of new suppliers,
including supplier selection and approval.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.Responsible for maintaining the Approved Supplier
List.Provide insight regarding supplier capabilities for new and
existing products, in collaboration with manufacturing,
engineering, R&D, and marketing.Conducts external supplier
audits, as assigned, to ensure QMS compliance. 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).
Ability to identify under-performing suppliers and work to improve
them or reduce defect occurrence rates, initiating transfer
activities to alternative suppliers when necessary.Consolidation of
supply base through identification of redundant capabilities and
initiating/supporting manufacturing or service transfers as
needed.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.Requirements: Bachelor of
Science degree in a technical discipline. 5-7+ years of quality
engineering in life sciences industry, supplier quality experience
strongly preferred.Proven track record with supplier selection,
approval, and management.Strong written/verbal communication skills
and demonstrated use of quality tools/methodologies.Working
knowledge of FDA/QSR, ISO, EU MDR standards, process validation,
product design control, CAPA, and FMEA methodologies. Proficient
with Microsoft Office applications, and willingness to learn
Infraredx ERP and PLM systems.Certified Internal Auditor and/or
experience performing Internal Audits strongly preferred.Current
ASQ and/or six sigma certifications preferred.
PI194b74e60ef1-25660-34482093
Keywords: InfraredX, Inc., Quincy , Senior Supplier Quality Engineer, Engineering , Bedford, Massachusetts
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