Job Description

Role: Sr. Quality Assurance Engineer - Full Time (Medical Devices)

Location: Santa Rosa, CA (On-site)

We're looking for a Sr. Quality Assurance Engineer to support the development and manufacturing of life-impacting technologies.

Responsibilities:

• Leading initiatives to maintain and improve the Quality Management System in compliance with FDA and ISO 13485 standards.
• Driving root cause investigations, CAPAs, and non-conformance processes.
• Partnering with cross-functional teams to support process validations, design controls, and risk management documentation.
• Assisting with internal and external audits, as well as regulatory inspections.
• Championing quality awareness and compliance across departments.

Requirements:

• 5+ years in Quality Assurance within a regulated industry (medical devices preferred).
• Strong understanding of FDA QSR, ISO 13485, and risk-based quality systems.
• Experience in process validation, equipment qualification, and supplier quality.
• Bachelor’s degree in Engineering, Life Sciences, or related field.

If you are interested in joining a team tackling meaningful challenges that improve patient lives please apply or reach out via [email protected]

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