Pilot Ops Quality Engineer: Validation & Process Excellence

Real Staffing Group; Irvine (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Real Staffing Group is seeking a Pilot Operations Senior Quality Engineer to support validation activities for the introducer sheath within the Transcatheter Heart Valve unit. The role focuses on ensuring manufacturing and development meet rigorous integrity, safety, and regulatory standards.

You will apply IQ/OQ/PQ and quality engineering principles to optimize complex processes, using Six Sigma, TOPP, and LEAN, review validations, and help develop validation strategies aligned with risk

Qualifications

• Must have a bachelor's degree in engineering with at least four years of relevant industry experience.
• A master's or Ph.D. in engineering with three or fewer years of experience is also considered.
• Preferred certifications include CQE, Six Sigma, or Lean Blackbelt.

Responsibilities

• Support validation activities for the introducer sheath within the Transcatheter Heart Valve unit, ensuring integrity, safety, and regulatory compliance.
• Apply IQ/OQ/PQ and quality engineering principles to optimize manufacturing processes; utilize Six Sigma, TOPP, and LEAN.
• Review equipment validations and participate in developing validation strategies aligned with risk assessments and regulatory requirements.
• Review process risk assessments and PFMEAs to verify critical process parameters and quality attributes.
• Confirm completion of prerequisite activities such as equipment qualification and software validation; verify sampling plans.
• Maintain technical content for risk management files and develop training/docs for production; coordinate technician tasks and knowledge transfer.

Skills

IQ

OQ

PQ

quality engineering

Six Sigma

Lean

statistical techniques

Education

Bachelor's degree in engineering

Master's or PhD in engineering

Tools

MS Office Suite

Job description

Real Staffing Group is seeking a Pilot Operations Senior Quality Engineer to support validation activities for the introducer sheath within the Transcatheter Heart Valve unit. The role focuses on ensuring manufacturing and development meet rigorous integrity, safety, and regulatory standards.

You will apply IQ/OQ/PQ and quality engineering principles to optimize complex processes, using Six Sigma, TOPP, and LEAN, review validations, and help develop validation strategies aligned with risk