Senior Quality Engineer - Medical Device CSV & Validation

JobDiva, Inc.; Hayward (CA); On-site; USD 70,000 - 87,000; Full time

Job summary

Primary Talent Partners has a new contract opening for a Sr. Quality Engineer in Hayward, CA. The role provides QA engineering support across product lines, from materials to finished devices, with focus on risk management and process validation to meet regulatory standards.

The position emphasizes collaboration with design and vigilance functions to address quality issues and drive continuous improvement in product quality; shift is 8AM–5PM, with a 6-month contract and potential extension.

Qualifications

• BA/BS in Engineering required with 3–5 years in Quality Engineering.
• Master’s degree can replace 2 years of experience; MBA/Engineering preferred.
• Lean or Six Sigma Green Belt or higher preferred.

Responsibilities

• Support manufacturing from raw materials to finished device; maintain risk management docs.
• Ensure product quality through validation and process controls.
• Conduct root-cause investigations and CAPA documentation.
• Collaborate with design, vigilance and engineering to drive improvements.

Skills

Quality engineering

Process validation

Risk management

CSV

cGMP

Documentation

Problem solving

Data analysis

Education

BA/BS Engineering

Master's degree preferred

Tools

Regulatory systems

Job description

Primary Talent Partners has a new contract opening for a Sr. Quality Engineer in Hayward, CA. The role provides QA engineering support across product lines, from materials to finished devices, with focus on risk management and process validation to meet regulatory standards.

The position emphasizes collaboration with design and vigilance functions to address quality issues and drive continuous improvement in product quality; shift is 8AM–5PM, with a 6-month contract and potential extension.