Senior Supplier Quality Engineer

Hi

My name is Karthik Mutyala and Im a Recruitment Manager with Stark Pharma specializing in pharmaceutical biotechnology and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.

If interested please send me your updated resume along with the best number and time to reach you.

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

• Bachelors 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

If you are not interested please feel free to refer your friends or colleagues who may be looking for an opportunity.