Senior Director, Medical Device Quality Assurance

Socket.dev; South San Francisco (CA); On-site; USD 210,000 - 300,000; Full time

Job summary

Neurona Therapeutics, a South San Francisco biotech company, is seeking a Director/Senior Director of Quality Assurance – Medical Device to lead the device quality systems for a combination product. The role drives QA strategy, device verification, and cross-functional collaboration with R&D, Regulatory, and Operations.

The ideal candidate has 10+ years in GMP-regulated quality roles for medical devices (Class II/III), strong leadership, and expertise in ISO 13485 and FDA guidelines.

Qualifications

• Bachelor’s degree in a relevant technical field and 10+ years of quality experience in a GMP-regulated environment.
• Experience with Class II or Class III medical devices.
• Strong leadership and mentoring abilities.

Responsibilities

• Develop, review and maintain quality systems related to device aspects of the product.
• Lead corrective action teams and develop action plans.
• Oversee verification activities and align QA staff priorities.
• Ensure compliance with FDA, ISO 13485 and ISO 14971.
• Coordinate audits and responses to regulatory inspectors.
• Build cross-functional relationships to maintain device quality.

Skills

Quality leadership

Regulatory knowledge

GMP compliance

Auditing

ISO 13485

Education

BA/BS in Microbiology/Biology/Chemistry/Engineering

Job description

Neurona Therapeutics, a South San Francisco biotech company, is seeking a Director/Senior Director of Quality Assurance – Medical Device to lead the device quality systems for a combination product. The role drives QA strategy, device verification, and cross-functional collaboration with R&D, Regulatory, and Operations.

The ideal candidate has 10+ years in GMP-regulated quality roles for medical devices (Class II/III), strong leadership, and expertise in ISO 13485 and FDA guidelines.