Supplier Quality Engineer

Job Title: Supplier Quality Engineer

Location: Burnsville, MN

Duration: 9+ Month Contract (Potential Extension)

Start Date: ASAP

Position Overview

We are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management, component qualification, and supplier development activities. This role will be responsible for ensuring suppliers consistently meet quality, regulatory, and performance requirements, with a strong focus on PCB components, testing methodologies, and supplier qualification processes.

The ideal candidate will have experience working with medical device suppliers, PCB assemblies, PPAP processes, supplier audits, and quality systems within FDA-regulated environments.

Key Responsibilities

Lead supplier selection, qualification, and performance monitoring activities

Manage supplier onboarding and component qualification processes, including PPAP submissions and approvals

Partner with suppliers to establish and evaluate PCB testing methods, inspection criteria, and acceptance standards

Review and validate functional, electrical, and verification testing processes for PCB components and assemblies

Ensure supplier processes and products meet design, quality, and regulatory requirements

Conduct supplier audits (onsite and remote) and drive corrective and preventive actions

Support development, validation, and continuous improvement of test methods and inspection processes

Collaborate with Engineering, Manufacturing, Quality, and Supply Chain teams to support design transfer and manufacturing readiness activities

Participate in DFMEA and risk management activities to identify and mitigate supplier-related risks

Monitor supplier quality performance metrics and drive continuous improvement initiatives

Required Qualifications

Bachelor’s degree in Engineering, Quality, or related technical discipline

Experience in Supplier Quality Engineering within the medical device industry

Strong knowledge of supplier qualification, component validation, and PPAP processes

Experience with PCB components, assemblies, and testing methodologies

Experience conducting supplier audits and managing supplier corrective actions

Understanding of design verification, validation, and risk management processes

Strong problem-solving, communication, and project management skills