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Staftonic LLC

Sr. Supplier Quality Engineer

Staftonic LLC, Minneapolis, Minnesota, United States, 55400

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Senior Recruiter at Staftonic, Passionate about connecting great people with great opportunities 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:

Bachelor’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.

Seniority level Mid‑Senior level

Employment type Contract

Job function Medical Equipment Manufacturing

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