Pilot Operations Senior Quality Engineer

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

The Pilot Operations Senior Quality Engineer will play a pivotal role in supporting validation activities for the introducer sheath within the Transcatheter Heart Valve business unit. This position focuses on ensuring that manufacturing processes and product development meet rigorous standards of integrity, safety, and regulatory compliance.

The successful candidate will apply their expertise in IQ/OQ/PQ and quality engineering principles to optimize complex manufacturing processes, utilizing methods such as Six Sigma, TOPP, and LEAN. Responsibilities include identifying opportunities for process improvement, reviewing and approving equipment validations, and participating in the development of validation strategies. The engineer will ensure that validation scopes align with intended use, risk assessments, and regulatory requirements, and will review process risk assessments and PFMEAs to verify that critical process parameters and quality attributes are addressed.

Additional duties involve confirming completion of prerequisite activities such as equipment qualification and software validation, verifying statistical rationale and sampling plans, and maintaining technical content for risk management files. The role also includes developing training and documentation materials for production, assigning and coordinating technician tasks, and supporting knowledge transfer across teams.

Candidates must hold a bachelor's degree in engineering or a related field 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 qualifications include CQE, Six Sigma, or Lean Blackbelt certifications. Strong documentation, communication, and interpersonal skills are essential, along with proficiency in MS Office Suite and statistical techniques. Experience with lab or industrial equipment is advantageous. The ideal candidate will demonstrate leadership, attention to detail, and the ability to manage competing priorities in a fast-paced, collaborative environment.

Must-Have Skills:

• IQ
• OQ
• PQ
• quality engineering
• Six Sigma
• Lean
• MS Office Suite
• statistical techniques

Nice-to-Have Skills:

• TOPP
• CQE
• lab equipment
• industrial equipment
• documentation
• relationship management
• problem-solving
• organizational
• analytical
• critical thinking
• leadership
• risk management
• PFMEA

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.