Job Description

Senior Quality Engineer – Class III Medical Device

Location: San Francisco Bay Area

Requirements:

• 5 days a week onsite
• No Sponsorship options

A leading Class III medical device company in the Bay Area is seeking a Senior Quality Engineer to drive quality assurance initiatives and ensure compliance with FDA, ISO 13485, and other regulatory standards. This role will focus on design control, risk management, CAPA, and process validation to support the development and manufacturing of life-saving medical technologies.

Key Responsibilities:

• Lead quality engineering activities in product development, design control, and risk management.
• Develop and execute process validations (IQ/OQ/PQ) and statistical data analysis.
• Support CAPA investigations, root cause analysis, and continuous improvement efforts.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Collaborate cross-functionally with R&D, manufacturing, and regulatory teams.

Qualifications:

• Bachelor’s degree in Engineering or related field.
• 5+ years of quality engineering experience in the medical device industry.
• Strong knowledge of Class III medical devices, risk management, and validation.
• Experience with design control, CAPA, and regulatory compliance.
• ASQ CQE or Six Sigma certification is a plus.

This is an exciting opportunity to make a direct impact in a fast-paced and innovative environment. Apply today to be part of a mission-driven team!

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