Senior Quality Engineer — IQ/OQ/PQ Validation, Med Device

Infosoft Inc.; Irvine (CA); Sur place; USD 130 000 - 150 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

IQ/OQ/PQ

PFMEA

Process risk assessment

Statistical methods

Lean Six Sigma

Validation documentation

CPPs & CQAs

Root-cause analysis

Technical documentation

Formation

Bachelor's degree in Engineering

Master's degree preferred

Outils

Microsoft Office Suite

Description du poste

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.