Senior Quality Engineer – Medical Device CSV & Validation

Lancesoft; Hayward (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Irvine, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished device, maintain Risk Management, and collaborate with design and vigilance functions to address quality issues and drive continuous improvement.

The role emphasizes validation activities (DQ/IQ/OQ/PQ), data integrity, and compliance with industry standards to keep processes in control and support regulatory requirements.

Qualifications

• Experience with process validation and risk management in medical devices.
• Strong engineering fundamentals and understanding of product/process interactions.
• Excellent written and verbal communication; capable of documenting in GDPs/cGMPs.
• Ability to update procedures and streamline processes for efficiency.

Responsibilities

• Evaluate operational data and documentation to drive corrective actions.
• Ensure product compliance through inspection criteria and procedures.
• Drive quality and manufacturing improvements to maintain state of control.
• Develop and analyze statistical data to ensure product quality.
• Perform root cause investigations and report negative trends.
• Coordinate computer system validation and software validation evaluations.
• Support data integrity initiatives across systems and equipment.
• Maintain Risk Management documentation including software risk.

Skills

Process validation

Risk management

Engineering depth

Communication skills

Procedures update

Education

BS in Engineering

Master’s degree preferred

Engineering/Business Administration background

Job description

Lancesoft in Irvine, CA is seeking a Quality Engineer to support manufacturing from raw materials to finished device, maintain Risk Management, and collaborate with design and vigilance functions to address quality issues and drive continuous improvement.

The role emphasizes validation activities (DQ/IQ/OQ/PQ), data integrity, and compliance with industry standards to keep processes in control and support regulatory requirements.