Job Details

The QA Director leads Quality management efforts at Cognoa, Inc. Reporting to the VP RA/QA, the QA Director develops and manages all aspects of Quality Assurance, including Software Quality Assurance, across the Company to meet applicable FDA regulations and support the regulatory submissions of Company’s SaMDs.

Duties/Responsibilities:

• Lead Quality (including Software Quality Assurance) across the company.
• Provide expertise on SaMD and interface with the product, clinical, software and machine learning teams to support DHF requirements for regulatory submissions and Cognoa’s QMS.
• Develop, improve and maintain Cognoa’s Quality Management System and processes including – but not limited to –document control, training, supplier management, audits, management reviews, etc.
• Direct internal and external audits related to ISO, FDA, State Regulatory Agencies, and business partners.
• Ensure management has an up-to-date understanding of the resources required to deliver Quality deliverables.
• Develop and build-out a Quality team and infrastructure to support Cognoa’s SaMD pipeline.

Required Skills/Abilities:

• Strong analytical and problem-solving skills.
• Strong technical writing skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to effectively communicate with employees using strong verbal and written communication skills.
• Ability to function well in a high-paced and at times stressful environment.

Education and Experience:

• B.S. degree or Advanced Degree in a Life Science or other relevant discipline.
• 10-15 years of relevant quality and / or regulatory experience.
• Submissions involving machine learning based SaMD strongly preferred
• Thorough knowledge of FDA guidances and regulations required, including 21 CFR 820, 21 CFR 11, as well as ISO 13485, ISO 14971, IEC 62366-1, IEC 62304. Knowledge of ex-US requirements highly desirable.