- Ensures that the company’s Approved Supplier List is maintained, and that designated supplier’s supporting the TPM remains compliant and suitable for use and their listing.
- Supports assessments of potential new suppliers and service providers for quality and quality system capabilities, as required.
- Communicates company approval requirements to the supplier and monitors feedback per project timelines. Supports on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
- Supports notification to appropriate stakeholders of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab or factors affecting the supply of materials or service to agreed documentation.
- Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation providing assistance in these efforts, as required.
- Assists in the evaluation and approval of supplier requested changes or improvements.
- Supports implementation of key controls related to critical aspects of the product/material, including non-conformance events.
- Assists new product development teams, as required.
- Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.
- Assists in notifying suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.
- Monitors supplier performance and reports supplier quality trend data.
- Trains Third Party Manufacturers on inspecting products on the behalf of the company
- Responsible for approving First Article Inspections, as initiated by suppliers.
- Supports internal, third party, and/or regulatory agency inspections, as needed.
- Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
- Quality Assurance experience in the Medical Device, pharmaceutical, or other quality managed regulated industries.
- Experience in quality assessments.
- Experience of working in the areas of Design Controls, Verification and Validation activities, manufacturing practices and statistical techniques.
- Third level relevant degree.