Sr. Supplier Quality Engineer
Staftonic LLCMinneapolis, MN, US16 hours ago
Job type
- Full-time
Job descriptionBachelor’s degree in Engineering, Quality, or a related discipline. Minimum 5 years of experience in Supplier Quality or Quality Engineering within a regulated industry (Medical Device experience strongly preferred). Strong working knowledge of ISO 13485 , FDA QSR , and supplier quality management systems. Hands-on experience with supplier qualification , process validation (IQ / OQ / PQ) , and change control . Excellent problem-solving, communication, and cross-functional collaboration skills.
Job Description
Position : Sr. Supplier Quality Engineer
Location : Minneapolis, MN
Duration : Long-Term Project
Key Responsibilities :
- Lead supplier qualification, evaluation, and management for new product introduction and commercialization.
- Develop and execute supplier control strategies, qualification plans, and risk assessments.
- Review and approve supplier change requests, material specifications, and documentation to ensure compliance with internal and regulatory standards.
- Partner with Design, Manufacturing, Quality, and Regulatory teams to ensure supplier readiness and robust validation of purchased materials and components.
- Drive root cause analysis and implement effective CAPAs to address supplier quality issues.
- Support continuous improvement initiatives to enhance supplier performance and process capability.
Qualifications :
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Supplier Quality Engineer • Minneapolis, MN, US
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