Senior Manufacturing Quality Engineer (IQ/OQ/PQ)

Infosoft Inc.; Irvine (CA); Presencial; USD 130.000 - 150.000; Jornada completa

Descripción de la vacante

Infosoft Inc. in Irvine, CA is seeking a Senior Manufacturing Quality Engineer (IQ/OQ/PQ) to lead validation activities in a regulated medical-device manufacturing environment. You will focus on manufacturing process validation, risk management, and continuous improvement for cardiovascular devices.

Ideal candidates bring hands-on IQ/OQ/PQ experience, PFMEA, statistical methods, and strong technical documentation skills, with collaboration across manufacturing, engineering, and quality teams.

Formación

• Hands-on experience in a regulated medical-device manufacturing environment.
• Experience with IQ/OQ/PQ, process validation, equipment qualification, or related validation activities.
• Strong PFMEA, process risk assessment, risk management, CPPs, and CQAs knowledge.
• Experience reviewing or developing validation protocols, acceptance criteria, sampling plans, and statistical rationale.
• Understanding of medical-device quality systems and regulatory requirements.
• Lean, Six Sigma, continuous improvement, root-cause analysis, or structured problem-solving experience.
• Ability to interpret technical documentation, manufacturing processes, and qualification activities.

Responsabilidades

• Support validation strategies, protocols, plans, and technical documentation.
• Evaluate manufacturing processes and equipment for quality, yield, and risk reduction.
• Review qualification and validation documentation for completeness.
• Ensure validation activities reflect intended use and regulatory requirements.
• Review PFMEAs and process risk assessments to confirm critical parameters and attributes are controlled.
• Coordinate with cross-functional teams to perform validation prerequisites and status updates.
• Prepare work instructions and training materials for transferring validated processes to manufacturing.

Conocimientos

IQ/OQ/PQ

PFMEA

Process risk assessment

Statistical methods

Lean Six Sigma

Validation documentation

CPPs & CQAs

Root-cause analysis

Technical documentation

Educación

Bachelor's degree in Engineering

Master's degree preferred

Herramientas

Microsoft Office Suite

Descripción del empleo

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.