Quality Engineer: Medical Device Validation & Risk

DivIHN Integration Inc; Hayward (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

DivIHN Integration Inc. in Irvine, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished device, maintaining risk management and coordinating with design and vigilance to drive quality improvements.

You will perform process validation, analyze data, ensure compliance, and lead computer system validation efforts (CSV) across software and hardware elements, while mentoring teams on quality systems and data integrity.

Qualifications

• Demonstrated experience on process validation and risk management for medical devices.
• Engineering depth and understanding of product/process interactions and design.
• Strong verbal and written communication skills; good documentation practices (cGDPs).
• Ability to update procedures and modify processes to improve efficiency.

Responsibilities

• Evaluate operational data to generate proactive actions reducing CIPM.
• Assure product compliance via inspection criteria; drive improvements.
• Develop/analyze statistical data and product specs for quality.
• Perform root cause investigations and document NCR/CAPA actions.
• Organize and perform computer system validation to support Master Validation Plan.
• Maintain Risk Management Documentation including software risk.
• Perform validation activities (DQ/IQ/OQ/PQ/TMV) as assigned.
• Partner with Project/Manufacturing Engineering for project transitions.
• Evaluate computer system validation for applicable software/GxP systems.

Skills

Process validation

Risk management

Written and verbal communication

Documentation practices (cGDPs)

Education

BA/BS in Engineering

Master’s degree preferred

Lean or Six Sigma Green Belt or higher preferred

Tools

Computer system validation (CSV)

GxP computerized systems

Job description

DivIHN Integration Inc. in Irvine, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished device, maintaining risk management and coordinating with design and vigilance to drive quality improvements.

You will perform process validation, analyze data, ensure compliance, and lead computer system validation efforts (CSV) across software and hardware elements, while mentoring teams on quality systems and data integrity.