Supplier Quality Engineer

• Lead and support supplier transfer activities, including validation of transferred processes, equipment, and measurement systems.
• Lead Part Production Approval Process (PPAP) and ensure alignment of supplier validation and qualification deliverables.
• Collect, review, and archive supplier documentation required for qualification, validation, and monitoring activities.
• Ensure robust validation protocols and reports are executed in alignment with regulatory and internal quality standards.
• Facilitate cross-functional collaboration with Engineering, Manufacturing, and Supply Chain during supplier transitions and process transfers.
• Assess and propose appropriate measurement systems to ensure capability and repeatability in manufacturing and supplier processes.
• Provide on-site support and oversight during manufacturing transfers, including presence on the manufacturing floor to evaluate processes, equipment setup, and operator readiness.
• Manage supplier change requests notified through the corporate SCR Portal.
• Review and acknowledge supplier notifications, verify content, and request additional information (scope, change description, supportive data) as needed.
• Draft and manage Change Request Forms (CRFs) based on supplier notification details; track CRF responses and send reminders for overdue actions.
• Support supplier quality contracts and technical agreements by reviewing content, requesting clarifications, and facilitating negotiations with suppliers.
• Maintain and update the Approved Supplier List (ASL); ensure compliance with quality system requirements.
• Track supplier remediation actions (containment, root cause analysis, corrective and preventive action) and ensure timely closure of SCARs and nonconformances.
• Support supplier performance monitoring and quarterly reviews with consolidated reporting on validation and transfer activities.
• Participate in supplier audits, ensuring validation and transfer requirements are properly evaluated.

• Bachelor of Science in Engineering or related technical discipline
• 3-5 years of experience in supplier quality within the medical device industry
• Strong experience in validation activities (process, equipment, and/or measurement system validation)
• Hands-on experience or exposure to manufacturing floor processes
• Proven knowledge and experience with supplier transfers and transfer processes
• Familiarity with PPAP, supplier change control, and regulatory requirements (ISO 13485, FDA, etc.)
• Excellent problem-solving, communication, and technical writing skills

• Onsite in Olive Branch, MS or Westminster, CO highly preferred, remote is possible
• 8-12+ month contract
• Start ASAP

GForce Life Sciences