Manufacturing 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

Job Title: Manufacturing Quality Engineer (IQ/OQ/PQ) - 2nd Shift

Pay Rate: $60 to $65/HR

Duration: 12 months

Location: Irvine, CA

2nd Shift: 3:30 PM- 2 AM (Monday-Thursday)

Our client is seeking a Manufacturing Quality Engineer (IQ/OQ/PQ) to support quality and validation activities within a regulated medical-device manufacturing environment. This position will focus on manufacturing process and equipment validation, risk management, statistical evaluation, and continuous improvement for technologies supporting cardiovascular medical-device products. The engineer will work closely with manufacturing, engineering, quality, and technical teams to ensure validation activities are appropriately planned, documented, and executed. Candidates should bring hands-on experience with IQ/OQ/PQ, PFMEA, process risk assessment, statistical methods, and medical-device quality systems.

• Support development and review of validation strategies, protocols, plans, and associated technical documentation.
• Evaluate manufacturing processes and equipment to identify opportunities for improved quality, yield, reliability, and risk reduction.
• Review qualification and validation documentation to confirm requirements are appropriately addressed.
• Assess whether proposed validation activities adequately reflect intended use, process risks, and applicable regulatory requirements.
• Review PFMEAs and process risk assessments and verify that critical process parameters and critical quality attributes are appropriately controlled.
• Evaluate validation prerequisites, including equipment qualification, fixture qualification, TMV, software validation, and drawing/document release status.
• Review sampling methodologies, statistical justification, acceptance criteria, and validation results for technical appropriateness.
• Contribute to updates of manufacturing risk-management documentation and related technical files.
• Apply Lean, Six Sigma, structured problem-solving, and engineering methods to support process improvement.
• Identify potential modifications to fixtures, tooling, equipment, or manufacturing methods to improve process performance and reduce risk.
• Review equipment validation and asset-management activities from a quality perspective.
• Prepare or update work instructions, technical documents, and training materials used to transfer validated processes into manufacturing.
• Provide technical direction to technicians conducting validation or engineering tests.
• Train technicians on testing requirements and provide technical feedback on execution.
• Coordinate quality and validation activities with cross-functional engineering, manufacturing, and quality teams.
• Maintain compliance with applicable quality-system procedures, safety requirements, and controlled documentation practices.

Requirements

• Bachelor's degree in Engineering or a related field with at least 4 years of relevant industry experience.
• Master's degree in Engineering or related discipline with approximately 3+ years of relevant experience is preferred.
• Hands-on experience in a regulated medical-device manufacturing environment.
• Demonstrated experience with IQ/OQ/PQ, process validation, equipment qualification, or related validation activities.
• Strong working knowledge of PFMEA, FMEA, process risk assessment, risk management,CPPs, and CQAs.
• Experience reviewing or developing validation protocols, acceptance criteria, sampling plans, and statistical rationale.
• Understanding of medical-device quality systems and regulatory requirements.
• Experience with Lean, Six Sigma, continuous improvement, root-cause analysis, or structured problem-solving.
• Ability to interpret and evaluate technical documentation, manufacturing processes, and equipment qualification activities.
• Strong technical documentation, analytical, communication, and problem-solving skills.
• Experience working directly with technicians and cross-functional engineering/manufacturing teams.
• Proficiency with Microsoft Office Suite.
• Experience with laboratory or industrial equipment is preferred.
• CQE, Six Sigma, or Lean Black Belt certification is preferred.
• Must be comfortable working in a collaborative, fast-paced, regulated manufacturing environment and managing multiple technical priorities.