Supplier Quality Engineer

GForce Life Sciences

Newark, NJ

JOB DETAILS
SALARY
$50–$60 Per Hour
SKILLS
Biology, Biotech and Pharmaceutical, Case Report Form (CRF), Change Control, Change Management, Change Order Management, Change Requests/Orders, Consulting, Corrective Action, Cross-Functional, Document Archiving, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Medical Equipment, Negotiation Skills, On Site Support, Performance Analysis, Production Part Approval Process (PPAP), Quality Engineering, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Requirements Management, Requirements Validation/Verification, Root Cause Analysis, Software Testing, Supply Chain, System Validation, Time Management, Validation Plan, Vendor/Supplier Evaluation, Vendor/Supplier Management
LOCATION
Newark, NJ
POSTED
Today

This range is provided by GForce Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range $50.00/hr - $60.00/hrDirect message the job poster from GForce Life SciencesOverview Consultant, Supplier Quality Engineer, Medical DevicesOur 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 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 discipline3-5 years of experience in supplier quality within the medical device industryStrong experience in validation activities (process, equipment, and/or measurement system validation)Hands-on experience or exposure to manufacturing floor processesProven knowledge and experience with supplier transfers and transfer processesFamiliarity 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 is possible8-12 month contractStart ASAPSeniority level Mid-Senior levelEmployment type ContractJob function Engineering and Quality AssuranceIndustries Medical Equipment Manufacturing, Biotechnology Research, and Engineering ServicesInferred details about location and compensation in the original posting have been removed to focus on current role information.#J-18808-Ljbffr

About the Company

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GForce Life Sciences