Senior MQE (IQ/OQ/PQ) - Validation & Process Improvement

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

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.