Senior Quality Engineer - Medical Device Validation & Risk

Us Tech Solutions; Hayward (CA); On-site; USD 180,466,000 - 191,486,000; Full time

Job summary

US Tech Solutions is seeking a Quality Engineer to support manufacturing operations at the Irvine facility, covering from raw materials to finished device. The role focuses on risk management, validation, and ensuring compliance with industry standards while collaborating with design and vigilance teams.

Responsibilities include executing validation activities (DQ/IQ/OQ/PQ), maintaining data integrity, and driving continuous quality improvements.

Qualifications

• BA or BS in Engineering with 3–5 years in Quality Engineering.
• Master’s degree can substitute for up to 2 years of experience.
• Lean or Six Sigma Green Belt or higher preferred.
• Strong written and verbal communication skills; good documentation practices (cGDPs).

Responsibilities

• Evaluate operational data and drive actions to reduce CIPM.
• Ensure product compliance through inspection criteria and processes.
• Develop and analyze statistical data to assure quality.
• Perform DQ/IQ/OQ/PQ validation activities and related documentation.
• Coach on CSV, SDLC, data integrity, and cyber security standards.

Skills

Process validation

Risk management

Documentation

SDLC

Cyber security

Education

Bachelor's degree in Engineering

Master's degree acceptable in lieu of experience

Lean or Six Sigma Green Belt preferred

Tools

Computer System Validation

Job description

US Tech Solutions is seeking a Quality Engineer to support manufacturing operations at the Irvine facility, covering from raw materials to finished device. The role focuses on risk management, validation, and ensuring compliance with industry standards while collaborating with design and vigilance teams.

Responsibilities include executing validation activities (DQ/IQ/OQ/PQ), maintaining data integrity, and driving continuous quality improvements.