Senior Quality Engineer (Regulatory)

Job Summary:

The Senior Quality Engineer leads cross-functional quality initiatives across the value chain to ensure robust product realization, compliance, and production readiness. This role is responsible for resolving complex quality issues, interpreting and aligning technical and regulatory requirements, and driving systemic improvements across supply chain, production, and customer performance.

Duties and Responsibilities: 

Complex Problem Resolution & Systemic Improvement

• Lead resolution of complex issues across supply chain, internal production, and customer/field performance


• Drive permanent corrective actions using RCCA, eliminating systemic defect drivers and recurring issues


• Lead improvements in process capability, defect reduction, and cost of poor quality (COPQ)


• Identify and resolve gaps between regulatory requirements and operational execution to ensure sustainable co...