Sr Supplier Qual Engineer

Job Title: Sr Supplier Qual Engineer
Job ID: 26621
Duration: 12 Months
Location: 7000 Central Ave NE Minneapolis Minnesota 55432 (Remote)
Pay Range: $55.00 - $60.00/hr.

Job Description:
Must-Have Skills
Supplier Quality Engineering
New Product Development (NPD) support
Supplier Qualification & Auditing
GMP and Regulatory Compliance
Quality Systems in Medical Device/Regulated Environment
Test Method Validation
Approved Supplier List (ASL) Management
Control Plans & Sampling Plans
Cross-functional Collaboration

Key Responsibilities
Qualify and manage suppliers to ensure quality parts, materials, and services.
Support Pre-Market Supplier Quality activities for New Product Development (NPD).
Partner with Component Engineering and Post-Market Supplier Quality teams.
Conduct supplier audits and assess supplier performance.
Manage Approved Supplier Lists (ASL), Control Plans, and Supplier-Owned Quality programs.
Develop product acceptance sampling strategies.
Define receiving inspection requirements and support test method validation.
Ensure supplier compliance with GMP, regulatory, and customer requirements.
Drive supplier quality improvements and defect prevention throughout the product lifecycle.

Preferred Candidate Background
Medical Device industry experience.
Supplier Quality experience supporting NPD programs.
Experience with supplier audits, PPAP/APQP, validation, and risk management.
Knowledge of FDA, ISO 13485, GMP, and quality systems.
Strong project management and stakeholder management skills.

Education & Experience
Bachelor's Degree in Engineering or related technical field.
4+ years of relevant experience required.
Advanced Degree with 2+ years of experience may be considered.