Senior Staff Quality Engineer

Hobson Associates; California (MO); On-site; USD 110,000 - 160,000; Full time

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.

Skills

Quality Engineering

Design Controls

Risk Management

Validation Protocols

Statistical Analysis

DOE

Regulatory Knowledge

Education

Bachelor of Science in Engineering

Job description

Senior / Staff Quality Engineer - Medical Device | Orange County, CA

I'm working with a growing medical device manufacturer in Orange County, CA, looking to add an experienced Quality Engineer to its team.

This is a highly visible, hands-on role for someone with strong experience in medical device product development, Design Controls, Risk Management, and Process Validation. You'll work closely with Engineering and Operations, supporting products from development through transfer into manufacturing.

What they're looking for:

• 5+ years of Quality Engineering experience within the medical device industry
• Strong Design Controls experience within product development
• Hands-on ISO 14971 Risk Management experience, including FMEAs, Hazard Analyses, Risk Management Plans/Reports, and Design Traceability
• Demonstrated experience writing and executing validation protocols - not simply participating in validation activities
• Experience with process development, verification/validation, and design transfer
• Working knowledge of FDA, ISO 13485, and EU MDR requirements
• Ability to work independently and serve as a key Quality resource on site
• Statistical analysis experience including process capability, DOE, sample-size determination, and related tools
• BS in Engineering or related technical discipline

This is an opportunity to take on a visible Quality role with significant ownership of Design Controls, Risk Management, and Validation activities supporting medical device development and manufacturing.

We're not able to consider candidates who require current or future visa sponsorship.