Supplier Quality Systems Engineer

Position: Supplier Quality Systems Engineer Location: Bothell, WA

Experience: 5+ years Contract: 12+ months (potential extension)

About the Role

We are seeking an experienced Supplier Quality Systems Engineer to ensure the quality of supplied parts and assemblies while driving continuous improvement across our supply chain. This role involves collaboration with cross-functional teams, proactive supplier engagement, and playing a key role in reducing non-conformances. Domestic and international travel up to 50% is expected.

Key Responsibilities

Resolve and prevent supplier-caused non-conformances to support manufacturing operations.

Lead supplier quality system and process audits (domestic and international).

Conduct and document part and process qualification activities.

Drive process improvements using supplier quality metrics.

Partner with cross-functional teams to prevent part shortages and ensure compliance with 21 CFR 820 and ISO 13485:2016.

Evaluate and support the selection of new suppliers.

Qualifications

• Required:

• 5+ years of experience in engineering, supplier quality, or related roles (medical device industry preferred).

• Bachelor’s degree in Engineering or Life Sciences.

• Strong communication, documentation, and organizational skills.

• Knowledge of 21 CFR 820 and ISO 13485:2016.

• Preferred:

• Master’s degree in Engineering or Life Sciences.

• ISO 13485 Lead Auditor certification.

• Experience auditing domestic and international suppliers.

• Strong project management skills.