What are the responsibilities and job description for the Supplier Quality Engineer position at Stark Pharma?
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
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
- 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