GForce Life Sciences

Lead supplier quality processes including validation, transfer activities, PPAP, supplier documentation, change requests, audits, and cross-functional collaboration to ensure regulatory compliance and operational efficiency. | Bachelor's degree in engineering, 8+ years supplier quality experience in medical devices, strong validation and manufacturing floor exposure, knowledge of PPAP, supplier change control, and regulatory standards like ISO 13485 and FDA. | Summary Our client, an innovative global leader within medical devices, has engaged GForce Life Sciences to provide a Senior Supplier Quality Engineer (SQE). The senior SQE will strategize and establish a baseline for supplier quality processes and turn over the QMS. The senior will need to be able to develop and lead others, understand the QMS thoroughly, and be driven to make change. Responsibilities • Draft & Implement process and procedure changes for more efficient execution while enhancing regulatory requirements. • Lead Continues Improvement initiatives to streamline operations and transfer activities • Mentor & coach others to gain proficiency related to process validation activities • Collaborate cross-functionally to eliminate redundant work and deliver on stakeholder expectations • 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. Requirements • Bachelor of Science in Engineering or related technical discipline • 8+ 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 Terms & Start • Onsite in Olive Branch, MS or Westminster, CO (3x/week first few months, then flexible) highly preferred, remote is possible • 8-12 month contract • Start ASAP