Senior Quality Engineer: Validation & Process Excellence

Ledgent Technology; Irvine (CA); On-site; USD 76,000 - 81,000; Full time

Job summary

Ledgent Technology in Irvine, CA seeks a Pilot Operations Senior Quality Engineer to lead validation activities for introducer sheath devices for THV. The role focuses on applying IQ/OQ/PQ and standard QA methods to ensure regulatory compliance and patient safety.

The candidate will review validations, assist in strategy development, and maintain risk management and training materials for production teams, with a strong emphasis on leadership and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Master's degree or Ph.D. in Engineering or related field preferred.
• CQE (Certified Quality Engineer), Six Sigma or Lean Black Belt certifications preferred.
• Proven MS Office proficiency and documentation skills required.

Responsibilities

• Identify and optimize complex manufacturing processes using Six Sigma, Lean, and related methods.
• Review and approve equipment validations and asset management actions.
• Develop validation strategies and review PVP/MVP scopes.
• Ensure validation scope aligns with use, risk, and regulatory requirements.
• Review PFMEAs and process risk assessments to verify CPPs and CQAs addressed.
• Coordinate prerequisite activities (equipment qualification, software validation, etc.).
• Develop training and documentation for production to transfer knowledge.
• Lead and coordinate technicians, assign tasks, and provide feedback.

Skills

Six Sigma

Lean

Leadership

Problem solving

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Ph.D. in Engineering

Tools

MS Office Suite

Job description

Ledgent Technology in Irvine, CA seeks a Pilot Operations Senior Quality Engineer to lead validation activities for introducer sheath devices for THV. The role focuses on applying IQ/OQ/PQ and standard QA methods to ensure regulatory compliance and patient safety.

The candidate will review validations, assist in strategy development, and maintain risk management and training materials for production teams, with a strong emphasis on leadership and cross-functional collaboration.