GForce Life Sciences
Summary
Our client, an innovative global leader within medical devices, has engaged GForce Life Sciences to provide a Supplier Quality Engineer (SQE). The SQE will help with supplier transfers and the transfer process. The SQE will support normal standard supplier quality processes, with the main focus on consolidating suppliers. Responsibilities
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. Lead and support supplier transfer activities, including validation of transferred processes, equipment, and measurement systems. Ensure robust validation protocols and reports are executed in alignment with regulatory and internal quality standards. 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. Support supplier quality contracts and technical agreements by reviewing content, requesting clarifications, and facilitating negotiations with suppliers. 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. 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. Facilitate cross-functional collaboration with Engineering, Manufacturing, and Supply Chain during supplier transitions and process transfers. Requirements
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.) Terms & Start
Onsite in Olive Branch, MS or Westminster, CO, highly preferred; remote on east coast is possible 12 month contract Start ASAP Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering, Quality Assurance, and Manufacturing Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
#J-18808-Ljbffr
Our client, an innovative global leader within medical devices, has engaged GForce Life Sciences to provide a Supplier Quality Engineer (SQE). The SQE will help with supplier transfers and the transfer process. The SQE will support normal standard supplier quality processes, with the main focus on consolidating suppliers. Responsibilities
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. Lead and support supplier transfer activities, including validation of transferred processes, equipment, and measurement systems. Ensure robust validation protocols and reports are executed in alignment with regulatory and internal quality standards. 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. Support supplier quality contracts and technical agreements by reviewing content, requesting clarifications, and facilitating negotiations with suppliers. 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. 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. Facilitate cross-functional collaboration with Engineering, Manufacturing, and Supply Chain during supplier transitions and process transfers. Requirements
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.) Terms & Start
Onsite in Olive Branch, MS or Westminster, CO, highly preferred; remote on east coast is possible 12 month contract Start ASAP Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering, Quality Assurance, and Manufacturing Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
#J-18808-Ljbffr