Senior Quality Engineer - Medical Devices & Validation

Actalent; Hayward (CA); On-site; USD 76,000 - 83,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Job summary

Actalent in Hayward, CA is seeking a Sr Quality Engineer to provide comprehensive quality engineering support across product lines, from raw materials to finished medical devices, and to maintain risk management processes.

The role focuses on process validation, CAPA, data integrity, and collaboration with design, vigilance, and manufacturing teams to ensure compliant, in-control operations.

Qualifications

• BA/BS in Engineering with 3–5 years of Quality Engineering experience.
• Experience in process validation for medical devices and risk management.
• Strong knowledge of GDP/cGDP and regulatory expectations.

Responsibilities

• Evaluate operational data and documentation to identify trends and drive improvements.
• Implement inspection criteria and procedures to ensure product quality.
• Develop and analyze statistical data to ensure compliant product quality.
• Investigate quality issues using structured problem-solving methods.
• Perform root-cause investigations and prepare CAPA reports.
• Document investigations within the quality system (NCR/CAPA).
• Organize CSV and software validation evaluations to support validation plans.

Skills

Process validation

Risk management

Quality engineering

GDP / cGDP

SDLC

Data integrity

Cybersecurity

Cross-functional

Education

BA/BS in Engineering

Tools

CSV validation

GxP systems

Job description

Actalent in Hayward, CA is seeking a Sr Quality Engineer to provide comprehensive quality engineering support across product lines, from raw materials to finished medical devices, and to maintain risk management processes.

The role focuses on process validation, CAPA, data integrity, and collaboration with design, vigilance, and manufacturing teams to ensure compliant, in-control operations.