Senior Supplier Quality Engineer

About the Role

The Senior Supplier Quality Engineer serves as a critical technical and quality liaison between DEKA, manufacturing partners, and the broader supplier base. This position is designed to ensure that suppliers consistently meet rigorous quality, regulatory, and performance expectations throughout the product lifecycle.

In this role, you will lead supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations. You will heavily support supplier qualification activities for NPI programs, including process validation support and the onboarding of new suppliers, while simultaneously managing the ongoing quality performance of production materials and services. Your work ensures supplier readiness for production launch, covering capacity, quality systems, and process controls, while driving robust qualification, development, and performance management processes.

How You Will Make an Impact

As a Senior Supplier Quality Engineer, you will drive the strategic oversight of the supplier ecosystem. You will lead risk-based supplier assessments aligned with product and process criticality, supporting selection decisions in collaboration with the Design Authority, Engineering, Procurement, and Quality Assurance. Your impact extends to conducting remote and onsite audits, reviewing critical documentation such as certifications and validations, and leading corrective action activities to ensure timely closure of quality issues.

You will also foster continuous improvement by conducting supplier performance reviews, supporting root cause analysis for nonconformances, and developing supply continuity and risk mitigation strategies. This role requires active participation in design transfer and process validation activities, ensuring that supplier input is effectively integrated into the broader engineering and quality framework.

Compliance and Collaboration

A core aspect of this position is ensuring strict adherence to applicable regulatory and quality system requirements, including 21CFR and ISO 13485. You will maintain and improve the Approved Supplier List (ASL) classification, manage supplier quality agreements, and support both external and internal audits. Success in this role depends on strong cross-functional collaboration with the Design Authority, Procurement, Manufacturing, and Engineering teams to support material nonconformance investigations and provide essential risk input to project teams.

Application Instructions

To apply, please submit your resume and relevant qualifications through our career portal. We are looking for candidates with a Bachelor's degree in Engineering, Life Sciences, or a related technical field, or equivalent experience in the regulated industry. Candidates with 3–5 years of experience in Supplier Quality or Quality Engineering within the medical device sector are encouraged to apply.

Equal Opportunity Employer

DEKA is an equal opportunity employer committed to building a diverse and inclusive workforce. We consider qualified applicants regardless of background, race, color, religion, gender, sexual orientation, gender identity, national origin, disability status, or protected veteran status. We welcome the opportunity to discuss reasonable accommodations during the application process.