Senior Quality Engineer – Medical Device CAPA Leader

Regulatory Jobs; Irvine (CA); In loco; USD 108.000 - 153.000; Tempo pieno

Descrizione del lavoro

Edwards Lifesciences is seeking a Manufacturing Sustaining Senior Quality Engineer to support 1st shift Irvine Implant Manufacturing operations. You will apply quality engineering principles to maintain compliant processes, drive CAPA, and lead improvements in a regulated medical-device environment.

Role emphasizes root-cause analysis, Six Sigma/Lean optimization, and collaboration with multi-disciplinary teams to ensure product quality and patient safety globally.

Competenze

• Bachelor’s degree in Engineering or Scientific field required.
• Master’s degree in Engineering or Scientific field with 3 years of experience preferred.

Mansioni

• Investigate complex manufacturing quality and compliance issues; analyze results and initiate corrective actions.
• Lead cross-functional teams to determine root causes, containment, and corrective actions to prevent recurrence.
• Develop and maintain risk management files and procedures; ensure alignment with regulatory standards.

Conoscenze

Quality Engineering

Product & Process Engineering

Quality Systems

Manufacturing

Formazione

Bachelor's degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Strumenti

MS Office Suite

Minitab

Descrizione del lavoro

Edwards Lifesciences is seeking a Manufacturing Sustaining Senior Quality Engineer to support 1st shift Irvine Implant Manufacturing operations. You will apply quality engineering principles to maintain compliant processes, drive CAPA, and lead improvements in a regulated medical-device environment.

Role emphasizes root-cause analysis, Six Sigma/Lean optimization, and collaboration with multi-disciplinary teams to ensure product quality and patient safety globally.