Consultant, Supplier Quality Engineer, Medical Devices
Summary
Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Supplier Quality Engineer. The SQE will focus on new product development and design controls.
Job Duties
Manage Supplier change request notified through the Corporate tool "SCR Portal"
Manage and acknowledge the reception of the supplier notification, check its content and ask for additional information to the supplier if needed (on scope, change description, supportive data), and initiate the Supplier change control.
When Change Request Form (CRF) request is required, draft the CRF request form based on supplier notification information
Track CRF responses and send reminders to responders when overdue
Prepare draft Quality & Technical Agreements for existing and new suppliers.
Manage change requests impacting Supplier Quality Contracts, check the content of the request and ask for additional information if needed to the requestor.
Manage simple requests like list of codes update in TA Appendix.
Support identification of prospective suppliers.
Implement Supplier Quality Approval Forms.
Support Supplier creation and monitoring in Aravo.
Facilitate, manage, and track supplier progress toward Approved status.
Draft agreements and facilitate corresponding supplier negotiations to implement quality contracts.
Lead Part Production Approval Process (PPAP).
Collect and archive all relevant Supplier documentation and required statements to qualify and monitor supplier.
Update Approved Supplier List to include new suppliers, update any unused suppliers to inactive status, etc.
Support Supplier Quality performance monitoring
Supplier investigation report evaluation against a business rating model
Issue 8D investigation reports (technical writing) for PIC (previously investigated complaints) based on standard reports / supplier reports.
Issue standard Customer investigation report for Customer complaints without traceability elements
Book and secure audit dates at Suppliers in line with audit plan and auditors team availability
When audit reports are available, archive audit reports in relevant systems.
Digitalize Nonconformance into Business system as well as Supplier remediation plan (containment, root cause, corrective and preventive action + due date).
Prepare reporting for Quarterly review, consolidate reports and data on NC supplier action plan execution, plan execution.
Maintain / ensure data are accurate in relevant systems (SCAR, ...)
Prepare reporting for Quarterly review, consolidate reports and data
Send supplier Surveys and review compliance to be ready for SQA accountable signature, archive in relevant systems.
Prepare Evaluation forms, archive in relevant systems (SQA SharePoint, ARAVO)
Support the Approved Supplier List maintenance/update the ASL.
Update the scrolling list in our SharePoint on Supplier Change Control, Supplier Quality Contract Ticket, Supplier Complaints
Requirements
Bachelor of Science in Engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
7-10 years of experience in a Quality Engineering and/or Supplier Quality role within Medical Devices