Senior Quality Assurance Manager
Quality & Regulatory
At Big Health, our purpose is to help millions back to good mental health. We do this by creating digital therapeutics: fully automated yet highly personalized programs that are scalable and clinically proven to work. Our programs harness the intimacy of the human voice and the power of animation to engage and entertain, while delivering complex concepts to help our users overcome their unique mental health challenges.
Reporting to the Vice President of Regulatory Affairs and Quality, you will be responsible for the development and administration of Big Health’s Quality Management System.
As Senior Quality Assurance Manager at Big Health, you will:
- Own and manage significant aspects of the Big Health Quality Management System.
- Support development, implementation, and management of Quality Management System (QMS) and related processes to ensure adherence to regulatory requirements.
- Implement and manage quality systems and training programs as necessary to support CAPA, complaint registration, inspection reporting and tracking
- Support software design control as well as verification and validation activities for Software as a Medical Device (SaMD) products in accordance with software planning procedures. This includes, but is not limited to review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
- Perform risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
- Participate in technical and management reviews to ensure design plans, product design and deliverables related to product software are met.
- Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
- Ensure compliance with relevant US FDA regulations, other country regulatory requirements, company policies, and procedures.
In order to be successful, you will need:
- 6+ years of Quality Management experience (system & design) in a healthcare environment.
- Familiarity with standards and regulations such as ISO 13485 and FDA Quality System regulations etc.
- Previous experience leading and managing significant components of a medical device quality system and demonstrated use of quality tools/methodologies
- Knowledge of regulations and standards affecting software as a medical device products.
- Cross-functional/cross-divisional experience.
- Clear and concise communication skills
- An interest in healthcare and wellness, and a passion for directly improving people’s lives
Life at Big Health:
- Join a diverse team of all backgrounds, we’re proud to be an equal opportunity over your work and freedom to input.
- Enjoy a clearly structured personal review and development program.
- Quarterly happiness survey that we use to ensure we’re creating a healthy and happy workplace for ourselves.
- Fund for spending on personal happiness
- Regular team and company events
- Generous vacation and maternity/paternity policy
- Competitive salary and equity package
More background on Big Health:
- Backed by leading venture capital firms, Index Ventures, Octopus Ventures, and Kaiser Permanente Ventures
- With offices in London and San Francisco, Big Health’s products are used by large multinational employers and major health plans to help improve sleep and mental health.
- To date, more than 12 million people across 60+ countries have access to Sleepio or Daylight
We at Big Health are on a mission to bring millions back to good mental health, in order to do so, we need to reflect the diversity of those we intend to serve. We’re an equal opportunity employer dedicated to building a culturally and experientially diverse team that leads with empathy and respect. Additionally, we will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance