Quality Assurance Engineer for Suppliers

Job Summary :

The Quality Assurance Engineer for Suppliers plays a crucial role in guaranteeing that Highridge Medical receives products of the highest quality from its suppliers. This is achieved by conducting thorough supplier qualifications, consistently monitoring supplier performance, and fostering strong relationships with suppliers to promote quality enhancements and implement necessary corrective actions.

Principal Duties and Responsibilities :

• Conduct activities for both supplier qualification and requalification.
• Evaluate supplier change requests and collaborate with suppliers to ensure smooth implementation of approved changes.
• Develop, implement, and uphold inspection criteria for Receiving Inspection departments.
• Compose and execute Test Method Validations (TMVs) related to receiving inspection tasks.
• Analyze product batch rejections from suppliers to evaluate their impact.
• Oversee supplier-related non-conformities in accordance with established internal procedures.
• Handle deviations issued by suppliers and those identified during Receiving Inspection.
• Compile data for Key Performance Indicators (KPIs) and Monthly Trending Reports concerning supplier activities.
• Lead and drive all supplier quality initiatives related to transferring production processes to new or existing suppliers.
• Manage Corrective and Preventive Actions (CAPA) resulting from supplier non-conformities.
• Oversee the issuance of Supplier Corrective Action Reports (SCAR), ensuring the communication, review, and resolution of corrective actions with suppliers.
• Assist in conducting supplier audits and internal Quality Management System (QMS) audits.
• Manage and coordinate changes with suppliers through Supplier Change Notifications (SCN).

This list of duties is not exhaustive and may not include all of the essential functions as defined under the ADA.

Expected Areas of Competence :

Education / Experience Requirements :

Travel Requirements : Up to 20%.