The Senior Quality Engineer ensures product quality and regulatory compliance for assigned product line(s) based on the quality system, design controls, continuous improvement, and best practice standards
Job Summary
The Senior Quality Engineer ensures product quality and regulatory compliance for assigned product line(s) based on the quality system, design controls, continuous improvement, and best practice standards.
Key responsibilities include assisting the Quality Assurance Site Manager with corrective actions, managing quality systems and processes, and fostering cross-functional relationships to drive QSR requirements.
The role involves influencing site compliance with quality policy, QMS procedures, and Quality Star guidelines, impacting quality system metrics like CAPA, training, and complaint resolution.
Matching Summary
The Senior Quality Engineer ensures product quality and regulatory compliance for assigned product line(s) based on the quality system, design controls, continuous improvement, and best practice standards.
Skills & Requirements
Must-have
Quality System Requirements (QSR)
design controls
process controls
CAPA
complaint management
risk management
Nice-to-have
Six Sigma
DFR
internal audits
conflict resolution
organizational leadership interaction
Key Requirements
Bachelor's degree
3 years of experience in regulated medical device or quality/regulatory assurance