Quality Systems Manager

Quality Systems Manager - Class III Medical Device
Bay Area, CA (Onsite/Hybrid) - Expected 3x a week

About the Role:
We are seeking a Quality Systems Manager to lead and maintain a compliant, scalable Quality Management System (QMS) for a Class III medical device organization. This role will be critical in ensuring adherence to FDA QSR, ISO 13485, and global regulatory requirements while supporting product development, manufacturing, and commercialization efforts. The ideal candidate brings experience navigating high-growth environments, including building quality systems that can withstand and scale through acquisitions or integration events.

Key Responsibilities:

• Own and continuously improve the Quality Management System (QMS) in alignment with FDA 21 CFR Part 820 and ISO 13485
• Lead internal and external audits, including FDA inspections and notified body audits
• Drive CAPA, nonconformance, deviation, and change control processes across the organization
• Ensure inspection readiness and act as primary point of contact during regulatory audits
• Partner cross-functionally with R&D, Manufacturing, Regulatory, and Supply Chain to ensure quality is embedded throughout the product lifecycle
• Support design control activities for Class III devices, including DHF, DMR, and DHR compliance
• Oversee supplier quality management and qualification activities
• Develop and track quality metrics, driving continuous improvement initiatives
• Support due diligence efforts and lead quality integration activities during acquisitions, ensuring seamless QMS alignment and compliance continuity
• Manage and mentor quality team members as the company scales

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field
• 7-10+ years of experience in medical device quality, with strong exposure to Class III devices (PMA preferred)
• Deep knowledge of FDA QSR (21 CFR Part 820) and ISO 13485
• Proven experience leading FDA inspections and regulatory audits
• Hands-on experience with CAPA, audits, change control, and design controls
• Demonstrated ability to maintain compliance through organizational change, including mergers, acquisitions, or rapid scaling environments
• Strong cross-functional leadership skills in fast-paced or startup environments preferred
• Experience with electronic QMS systems (eQMS)

Preferred:

• Background supporting PMA submissions or post-market quality for high-risk devices
• Experience in a startup or growth-stage company bringing products to market
• Direct involvement in acquisition integration, quality system harmonization, or diligence activities
• ASQ certification (CQE, CQA)

Why Join:

• Opportunity to shape and scale the quality system at a critical stage of growth
• High-impact role working on cutting-edge Class III medical technologies
• Exposure to strategic initiatives including acquisitions and organizational scaling
• Collaborative, mission-driven team focused on patient outcomes