Senior Quality Engineer - Medical Devices (Design Controls)

Hobson Associates

California (MO)

On-site

USD 110,000 - 160,000

Full time

2 days ago

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Job summary

Hobson Associates in Orange County, CA seeks a Senior/Staff Quality Engineer to lead quality activities from development through transfer to manufacturing. The role emphasizes Design Controls, ISO 14971 risk management, and robust validation protocols on complex medical device projects.

The candidate should bring hands-on experience with regulatory standards (FDA, ISO 13485, EU MDR) and strong statistical analysis skills, including DOE and process capability, to drive product quality and

Qualifications

5+ years of Quality Engineering experience in medical devices.
Strong Design Controls experience in product development.
Hands-on ISO 14971 Risk Management, including FMEAs and Hazard Analyses.
Proven ability writing and executing validation protocols.
Experience with process development, verification/validation, and design transfer.
Knowledge of FDA, ISO 13485, and EU MDR requirements.
Independent worker and on-site Quality resource.
Experience with statistical methods, DOE, and process capability.

Responsibilities

Own Quality responsibilities on site from development through transfer to manufacturing.
Lead risk management efforts and validation activities for medical devices.