- 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.
- 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.
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Senior Supplier Quality Engineer - Bedford, United States - Infraredx
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:
Requirements:
