Validation-Driven Quality Engineer (IQ/OQ/PQ) - 2nd Shift

Infosoft Inc.; Irvine (CA); On-site; USD 83,000 - 90,000; Full time

Job summary

Infosoft Inc. in Irvine, CA is seeking a Manufacturing Quality Engineer (IQ/OQ/PQ) to ensure validation activities within a regulated medical-device manufacturing environment.

You will focus on manufacturing process and equipment validation, risk management, statistical evaluation, and continuous improvement for cardiovascular devices. The role requires hands-on IQ/OQ/PQ, PFMEA, process risk assessment, and statistical methods, with collaboration across manufacturing, engineering, quality, and

Qualifications

• Bachelor's degree in Engineering with at least 4 years of relevant industry experience.
• Master's degree in Engineering preferred with ~3+ years of experience.
• Hands-on experience in a regulated medical-device manufacturing environment.
• Experience with IQ/OQ/PQ, process validation, and equipment qualification.
• Strong knowledge of PFMEA, risk assessment, CPPs, and CQAs.
• Experience developing validation protocols and sampling plans.
• Understanding of medical-device quality systems and regulatory requirements.
• Lean, Six Sigma, continuous improvement and root-cause analysis preferred.
• Ability to interpret technical documentation and validation activities.
• Experience working with technicians and cross-functional teams.
• Proficiency with Microsoft Office.
• CQE, Six Sigma, or Lean Black Belt preferred.

Responsibilities

• Support development and review of validation strategies, protocols, and related documentation.
• Evaluate manufacturing processes and equipment to improve quality, yield, and reliability.
• Review qualification and validation documentation to ensure requirements are met.
• Assess whether validation activities reflect intended use and regulatory requirements.
• Review PFMEAs and process risk assessments to ensure control of CPPs and CQAs.
• Evaluate prerequisites including equipment qualification, fixture qualification, TMV, and software validation.
• Review sampling methodologies, statistical justification, and acceptance criteria.
• Contribute to updates of manufacturing risk-management documentation.
• Apply Lean, Six Sigma and structured problem solving to improve processes.
• Provide technical direction to technicians and coordinate with cross-functional teams.
• Maintain compliance with quality-system procedures and controlled documentation.

Skills

PFMEA

Process risk assessment

Statistical methods

Lean Six Sigma

Structured problem-solving

Regulatory requirements

Quality documentation

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

Infosoft Inc. in Irvine, CA is seeking a Manufacturing Quality Engineer (IQ/OQ/PQ) to ensure validation activities within a regulated medical-device manufacturing environment.

You will focus on manufacturing process and equipment validation, risk management, statistical evaluation, and continuous improvement for cardiovascular devices. The role requires hands-on IQ/OQ/PQ, PFMEA, process risk assessment, and statistical methods, with collaboration across manufacturing, engineering, quality, and