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.
- Manage supplier issues arising at incoming inspection or on manufacturing floor.
- Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
- Lead the qualification of new suppliers, including supplier selection and approval.
- Responsible for coordinating initial component quality requirements, including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
- Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
- Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance to Infraredx standards.
- Execute and enforce Supplier and/or Distributor Quality Agreements.
- Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
- Lead the review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
- Generate KPI's and supplier metrics, including producing quarterly scorecards for supply base as defined.
- Ability to identify under-performing suppliers and work with them to improve or reduce defect occurrence rates, initiating transfer activities to alternative suppliers if 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.
- Ability to work independently, managing all requirements of supplier management program. Where possible, propose and implement continuous improvements for responsible areas.
- Mentor and develop quality personnel and/or organizational partners.
- Support contract manufacturers on quality issues resolution and change requests.
Requirements:
- Bachelor of Science degree in a technical discipline. Engineering discipline required.
- 10+ years of quality engineering in life sciences industry, 5+ years supplier quality experience required.
- Self-sufficient. Able to research and understand foreign manufacturing processes and provide input on process improvements and/or defect resolution. Role may require periodic meetings during off-hours to support or address issues arising at foreign manufacturers.
- Proven track record with supplier selection, approval, and management.
- Prior management or supervisory experience preferred.
- 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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