Senior Quality Engineer: Medical Device Validation & Risk

eTeam; Hayward (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

eTeam is seeking a Sr. Quality Engineer in Hayward, CA to support multiple product lines from materials to finished devices. You will manage risk, validation activities (DQ/IQ/OQ/PQ), and data integrity across GxP systems while collaborating with design, vigilance, and manufacturing teams.

The role emphasizes maintaining processes in control, applying problem-solving methods, and mentoring teams on CSV and regulatory expectations. This is a 6-month assignment at our Hayward facility.

Qualifications

• Minimum of a BA or BS in Engineering.
• Master’s degree can be used in lieu of 2 years of experience.
• Lean or Six Sigma belt or higher is preferred.

Responsibilities

• Evaluate manufacturing data to reduce CIPM and improve quality.
• Ensure product compliance through inspection criteria and process controls.
• Develop and analyze statistical data to ensure product 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.

Skills

Process validation

Risk management

Data integrity

SDLC

Cyber security

Education

BA/BS in Engineering

Master's degree preferred

Tools

Validation software

Job description

eTeam is seeking a Sr. Quality Engineer in Hayward, CA to support multiple product lines from materials to finished devices. You will manage risk, validation activities (DQ/IQ/OQ/PQ), and data integrity across GxP systems while collaborating with design, vigilance, and manufacturing teams.

The role emphasizes maintaining processes in control, applying problem-solving methods, and mentoring teams on CSV and regulatory expectations. This is a 6-month assignment at our Hayward facility.