Quality Assurance Manager

San Francisco
Diagnostics
Full-Time
COMPANY
Mammoth Biosciences is harnessing the diversity of nature to power the next generation of CRISPR products. Through the discovery and development of novel CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to democratize disease detection with an easy and affordable point-of-care test that allows real-time and simultaneous detection of multiple conditions. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13 and Cas14, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in San Francisco, Mammoth Biosciences is co-founded by CRISPR pioneer Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Mayfield, NFX, and 8VC, Decheng and leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.

DESCRIPTION
The QA Manager is responsible for assisting in designing, developing, and maintaining the Device Quality Management System. This includes oversight in training, document control, management review, risk management, and ensuring compliance with regulatory bodies.
The QA Manager will manage a system for centralized quality device data collection and analysis to drive continuous improvement.

Requirements

    • Minimum of a Bachelor of Science Degree in Engineering or similar scientific field with at least 10 years of validation experience in the medical device or combination products industry
    • At least 5 years of direct managerial responsibility leading all aspects of Quality System for Medical Devices
    • Extensive experience and understanding of design, development, verification and validation processes
    • Exceptional working knowledge and understanding of Device and Combination products regulations (21CFR 820 and ISO 13485), Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance
    • Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPoint
    • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual

Preferred Qualifications

    • Collaborate with functional leads to design and build Quality System processes to work with existing systems and product pipelines
    • Design, develop, approve, and implement Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design control and Validations processes
    • Perform and review/approve design control and risk management activities
    • Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design
    • Work effectively and influence multiple functions (R&D, Operations, Product/Program, Regulatory, Supply Chain, Medical, etc.) to ensure Quality expectations are met
    • Develop/oversee the FMEAs and other risk assessment processes and documentation (as required)
    • Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971:2012
    • Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures, FDA, and other medical device regulations
    • Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures
    • Represent the company as a Quality Assurance subject matter expert during internal and external regulatory inspections
    • Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies
    • Develop Supplier Management process, from initial sourcing through development, tooling and commercial phases as well as sustaining supplier activities
    • Monitor, track/trend all KPI and periodically provide a summary report to senior management, including participation in Management Review meetings
    • Provide coaching to QA, product development key stakeholders personnel on Quality Systems requirements and process improvement methodologies

Benefits

    • Competitive salary
    • Full health/vision/dental benefits
    • Unlimited vacation
    • Free breakfast/lunch/dinner/barista
    • Free gym
    • Public transportation commuter subsidy
    • 401(k) matching