Senior Manufacturing Quality Engineer (IQ/OQ/PQ)

Infosoft Inc.; Irvine (CA); On-site; USD 75,000 - 107,000; Full time

Job summary

Infosoft Inc. in Irvine, CA, seeks a Senior Manufacturing Quality Engineer (IQ/OQ/PQ) to support quality and validation activities in a regulated medical-device manufacturing environment.

You will focus on manufacturing process and equipment validation, risk management, statistical evaluation, and continuous improvement for cardiovascular medical-device products, collaborating with manufacturing, engineering, quality, and technical teams.

Qualifications

• Bachelor's degree in Engineering or related field with 4+ years of industry experience.
• Master's degree in Engineering or related discipline with ~3+ years of experience preferred.
• Hands-on experience in a regulated medical-device manufacturing environment.

Responsibilities

• Support validation strategies, protocols, and related technical documentation.
• Evaluate manufacturing processes and equipment to improve quality and yield.
• Review qualification and validation documents to ensure requirements are met.
• Assess validation activities against use, risks, and regulatory requirements.
• Review PFMEAs and process risks to ensure proper control of critical parameters.
• Coordinate validation prerequisites including equipment/fixture qualification and software validation.

Skills

IQ/OQ/PQ

PFMEA

Process risk assessment

Statistical methods

Lean Six Sigma

Structured problem-solving

Quality systems

Regulatory requirements

Microsoft Office

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Microsoft Office

Job description

Job Title: Senior Manufacturing Quality Engineer (IQ/OQ/PQ)

Pay Rate: $66/HR

Duration: 12 months

Location: Irvine, CA

Our Client is a Global medical device Manufacturer.

Our client is seeking a Senior 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 manufacturingenvironment.
• 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.