Senior Supplier Quality Engineer — Medical Devices (Onsite)

Stark Pharma; Bothell (WA); On-site; USD 85,000 - 110,000; Full time

Job summary

Stark Pharma is seeking a Senior Supplier Quality Engineer in Bothell, WA to support supplier quality operations in a medical device manufacturing setting. This role emphasizes driving supplier quality improvements, resolving non-conformance issues, and ensuring adherence to regulatory standards.

The ideal candidate will have over 5 years of experience in supplier quality engineering and strong knowledge of FDA and ISO standards. Responsibilities include leading audits and monitoring supplier performance metrics.

Qualifications

• Minimum 5+ years of experience in Supplier Quality, Quality Engineering, or related roles within the medical device industry.
• Experience conducting supplier audits and managing supplier quality systems.
• Strong communication, documentation, and problem-solving skills.

Responsibilities

• Investigate, resolve, and prevent supplier-related non-conformances impacting manufacturing operations.
• Drive supplier corrective and preventive actions to improve product quality.
• Conduct and document part qualification and process validation activities.

Skills

Supplier Quality Engineering

FDA 21 CFR Part 820 knowledge

ISO 13485:2016 requirements knowledge

Supplier Audits

Problem-Solving Skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Stark Pharma is seeking a Senior Supplier Quality Engineer in Bothell, WA to support supplier quality operations in a medical device manufacturing setting. This role emphasizes driving supplier quality improvements, resolving non-conformance issues, and ensuring adherence to regulatory standards.

The ideal candidate will have over 5 years of experience in supplier quality engineering and strong knowledge of FDA and ISO standards. Responsibilities include leading audits and monitoring supplier performance metrics.