Principal Quality Engineer

Principal Quality Engineer

📍 Location: Bay Area
🕒 Full-Time | Onsite

Join our mission-driven team, a pioneering medical device company specializing in radiotherapy systems that are transforming patient care worldwide.

We are seeking a Principal Quality Engineer to lead quality initiatives across the product lifecycle-from design and development to manufacturing and post-market surveillance. This is a high-impact role ideal for a quality expert who thrives in a fast-paced, collaborative environment and is driven by innovation and excellence.

Key Responsibilities

• Serve as the quality lead for new product development and design changes, ensuring compliance with FDA, ISO 13485, and IEC 60601 standards
• Drive risk management activities (ISO 14971), including FMEA, hazard analysis, and design reviews
• Lead root cause investigations and CAPA activities for complex quality issues
• Collaborate cross-functionally with R&D, Regulatory, Manufacturing, and Clinical teams to ensure quality is built into every stage of the product lifecycle
• Support internal and external audits, including FDA inspections and Notified Body audits
• Mentor junior engineers and contribute to continuous improvement of the QMS

Qualifications

• Bachelor's degree in Engineering or related technical field (Master's preferred)
• 8+ years of experience in medical device quality engineering, with at least 3 years in a senior or principal role
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and IEC 60601
• Experience with radiotherapy, imaging, or Class II/III electromechanical devices strongly preferred
• Excellent problem-solving, communication, and leadership skills

Ready to make a difference? Apply today and help us shape the future of cancer care.

To apply, send your resume to adam.tizabi@epmscientific.com