Head of Quality Assurance & Compliance
Q Bio
Legal, Quality Assurance
San Carlos, CA, USA
Posted on Oct 15, 2024
Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a person’s physiology for sharing with physicians and specialists anywhere in the world.
Join us!
Q Bio’s clinical digital twin platform, Gemini, is the first to capture and monitor comprehensive baseline patient health in a scalable virtual model. The Gemini Dashboard highlights the most important chemical and anatomical changes in an individual weighted by an individual’s lifestyle, genetic and medical history, that can be securely shared with physicians and specialists all over the world.
Gemini is powered by the fastest, most accessible, whole body scanner developed: the Mark I. Self-driving and optimized for primary care, the Mark I can complete a whole-body scan in 15 minutes or less in an open space, without radiation, breath holds, or claustrophobia. Patient comfort is maximized with the option to sit, stand, or lie down, and real-time telemetry is displayed throughout.
Why should you consider a career with Q Bio?
We dream big. Our team is aligned and excited about the opportunity to save lives and understand the human body like never before. We know how critical empowering and supportive leadership is, both to our excellence as a company, and for our team experience as a whole, and our leadership team will empower and support career growth. We’re a team of engineers, scientists, and operators who come from a diverse background of disciplines and experiences. We value teamwork, growth, determination and persistence, commitment to collaboration, and a reliance on staying nimble while keeping the big picture in mind.
The Head of Quality is responsible for the oversight and management of Q Bio’s Quality Management System, including design controls, manufacturing quality, and audit compliance. The Head of Quality must develop and/or create and review quality procedures and processes, provide of guidance and consultation for domestic and international regulatory requirements, interact with governmental agencies, and ensure compliance with quality system requirements. This role is also responsible for providing Quality guidance to Q Bio executive management and must be aware of current developments and potential changes and opportunities in U.S. and other regulatory jurisdictions.
Principal Duties & Responsibilities
- Lead all Q Bio’s Quality function supporting product quality and customer satisfaction in a fast-paced, highly technical environment.
- Establish, maintain, and monitor procedures and processes to ensure ongoing compliance with quality system regulations (21 CFR 820s and ISO 13485).
- Hire, manage, and develop high-performing quality professionals to maximize their potential and support the organization in achieving key business objectives.
- Develop departmental strategy and manage function to achieve key business objectives.
- Collaborate with senior leadership to provide a quality-first mindset and strategic guidance on quality-related topics, including changing or emerging regulatory/compliance requirements.
- Interface with regulatory bodies such as FDA and notified body during inspections and audits.
- Lead with a quality culture by continually conceiving of improvements and communicating and educating the organization on processes and behaviors.
- Develop and implement a common platform of quality and compliance systems, tools, procedures, and standards company-wide to support compliance and improve efficiencies.
- This is not an exhaustive list of duties or functions and may not necessarily comprise all "essential functions".
Expected Areas of Competence
- Medical device quality assurance and quality systems experience is required (21 CFRs 820s and ISO 13485)
- Experience supporting product development and manufacturing of medical devices, including hardware and software-based medical devices. Imaging product knowledge is desirable.
- Ability to develop and champion an organizational culture that promotes behaviors that lead to superior business performance.
- Ability to foster individual and group development by identifying and arranging appropriate assignments, formal training, or other experiences. Develop emerging talent to assume new or increased responsibilities in the future.
- Exhibit good business sense, capable of identifying business needs and opportunities relative to products and services.
- Strong problem-solving skills with demonstrated experience in providing compliant and pragmatic solutions.
- Demonstrate ability to learn key products (both hardware and software) and process knowledge quickly.
- Strong written and verbal communication and interpersonal skills.
Education & Experience Requirements
- Bachelor’s degree in a relevant field (e.g., engineering, materials science, or life science).
- 10+ years of experience in medical device Quality, 5+ years in progressive leadership roles.
- Extensive experience in medical device operations, which enables first-hand knowledge of manufacturing, QC/QA, and interface with R&D.
- Master’s degree in relevant field.
- CQE/CQA preferred.
- Working knowledge of Agile SW development practices, ISO 62304, ISO 14971, and IEC 60601 standards.
Preferred
Q Bio was founded in 2015 by serial entrepreneur Jeffrey Kaditz, Dr. Michael Snyder, Chair of Genetics and Director of Personalized Medicine at Stanford University, and Dr. Garry Choy, physician, radiologist, and former Chief Medical Information Officer at Mass General Hospital. Q Bio has raised over $80M from world class investors including Andreessen Horowitz, Kaiser Foundation Hospitals, Khosla Ventures, Founders Fund, SciFi VC, and many more.
Q Bio is an Equal Opportunity Employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.