About this opportunity
GForce Life Sciences lists this Supplier Quality Engineer opportunity in newark, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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/hr
Direct message the job poster from GForce Life Sciences
Overview
Consultant, Supplier Quality Engineer, Medical Devices
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
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
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 is possible
8-12 month contract
Start ASAP
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Quality Assurance
Industries
Medical Equipment Manufacturing, Biotechnology Research, and Engineering Services
Inferred details about location and compensation in the original posting have been removed to focus on current role information.
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Worksite address
newark, NJ, 07175, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.