Job Description
Supplier Quality Engineer
Location: Bloomington, Minnesota
Long Term Project
Key Responsibilities:
- Evaluate, qualify, and manage suppliers, CM/OEM partners, and materials for new product launches.
- Develop and maintain supplier controls, qualification plans, and reports.
- Review and approve supplier change requests and material specifications.
- Partner with Design, Manufacturing, Quality, and Regulatory teams to ensure robust supplier qualification and validation.
- Drive corrective and preventive actions (CAPA) to resolve complex supplier quality issues.
Qualifications:
- Bachelor’s degree in Engineering, Quality, or related field.
- 5+ years of Supplier Quality or Quality Engineering experience in a regulated industry (medical device preferred).
- Strong knowledge of ISO 13485, FDA QSR, and supplier management processes.
- Experience with supplier qualification, validation (IQ/OQ/PQ), and change management.