Senior Supplier Quality Engineer

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

Job Title: Senior Supplier Quality Engineer

Location: Bothell, WA (100% Onsite)

Duration: 6+ Month Contract

Job Summary

We are seeking a Senior Supplier Quality Engineer to support supplier quality operations within a medical device manufacturing environment. This role will focus on driving supplier quality improvements, resolving non-conformance issues, and ensuring compliance with regulatory and quality standards across the supply chain. The ideal candidate will have strong experience in supplier quality engineering, supplier audits, and manufacturing process improvements within FDA-regulated medical device environments.

Key Responsibilities

• Investigate, resolve, and prevent supplier-related non-conformances impacting manufacturing operations
• Drive supplier corrective and preventive actions to improve product quality and process performance
• Support implementation of design and manufacturing process changes at supplier sites
• Conduct and document part qualification and process validation activities
• Partner cross-functionally with Engineering, Manufacturing, Supply Chain, and Quality teams to prevent supplier-driven shortages and quality issues
• Lead supplier quality system and process audits to ensure compliance with company and regulatory requirements
• Monitor supplier performance metrics and identify opportunities for continuous improvement
• Support evaluation, qualification, and onboarding of new suppliers
• Participate in departmental meetings, training sessions, and continuous improvement initiatives

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field
• Minimum 5+ years of experience in Supplier Quality, Quality Engineering, or related roles within the medical device industry
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485:2016 requirements
• Experience conducting supplier audits and managing supplier quality systems
• Strong communication, documentation, and problem-solving skills
• Excellent organizational skills and attention to detail