Supplier Quality Engineer

Stark Pharma; Burnsville (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is seeking a Supplier Quality Engineer in Burnsville, MN. This role focuses on managing supplier quality, including selection, qualification, and performance monitoring, particularly for PCB components.

The ideal candidate will have a Bachelor's degree in Engineering or Quality, along with experience in the medical device sector. The position involves leading audits and collaborations with cross-functional teams to ensure compliance with regulatory requirements.

Qualifications

• 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.

Responsibilities

• Lead supplier selection, qualification, and performance monitoring activities.
• Conduct supplier audits and drive corrective and preventive actions.
• Collaborate with teams to support design transfer and manufacturing readiness activities.

Skills

Supplier qualification

PCB testing methodologies

Supplier audits

Project management

Problem-solving

Education

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

Job description

Overview

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.

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