Supplier Quality Engineer

GForce Life Sciences; Newark (NJ); Hybrid; USD 68,880 - 82,656; Full time

Job summary

A leading life sciences recruiting agency is seeking a Supplier Quality Engineer to manage supplier transfers and quality processes. The position is contract-based with a preferred onsite location but allows for remote work. Candidates should have experience in validation activities and knowledge of regulatory compliance in the medical device industry.

Qualifications

• 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).
• Proven knowledge and experience with supplier transfers and transfer processes.

Responsibilities

• Lead and support supplier transfer activities.
• Ensure robust validation protocols are executed.
• Manage supplier change requests.

Skills

Supplier quality management

Validation activities

Regulatory compliance knowledge

Manufacturing process knowledge

Cross-functional collaboration

Education

Bachelor of Science in Engineering or related technical discipline

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.