Senior Quality Engineer: Medical Device Validation & Risk

VIVA USA Inc; Hayward (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

VIVA USA Inc in California seeks a Quality Engineer to provide Quality Engineering support across product lines from raw materials to finished devices. The role maintains risk management documentation and supports validation activities, collaborating with design and vigilance to address quality issues and drive continuous improvement.

The ideal candidate has 3–5 years in Quality Engineering, a BA/BS in Engineering, and Lean/Six Sigma Green Belt or higher, with strong communication and

Qualifications

• Minimum BA/BS in Engineering with 3–5 years in Quality Engineering.
• Lean or Six Sigma Green Belt or higher preferred.
• Experience with process validation and risk management for medical devices.
• Strong communication and documentation skills (cGDPs).

Responsibilities

• Evaluate manufacturing process data to drive proactive actions and CIPM reductions.
• Ensure product compliance through inspection criteria and procedures.
• Develop and analyze statistical data and product specifications for quality.
• Perform computer system validation (CSV) and support data integrity initiatives.
• Coach and mentor on CSV, SDLC, data integrity, and cyber security standards.

Skills

Process validation

Risk management

CSV / SDLC

Data integrity

GxP practices

Education

BA/BS in Engineering

Master's degree preferred

Job description

VIVA USA Inc in California seeks a Quality Engineer to provide Quality Engineering support across product lines from raw materials to finished devices. The role maintains risk management documentation and supports validation activities, collaborating with design and vigilance to address quality issues and drive continuous improvement.

The ideal candidate has 3–5 years in Quality Engineering, a BA/BS in Engineering, and Lean/Six Sigma Green Belt or higher, with strong communication and