At Better Therapeutics, we seek to improve the system of care for chronic diseases caused by behaviors. We are developing FDA-regulated, prescription digital therapeutics (software) for treating diabetes, heart disease, and other cardiometabolic conditions. These conditions affect half of all adults and account for more than 80% of all health care spending. Currently, prescription medications are used to treat the symptoms of these diseases, while leaving the causes in place. Our digital therapeutics deliver nutritional CBT, a novel form of behavioral therapy that changes the brain so that lasting changes in behavior are possible. Data generated through patient use and remote monitoring enable treatment to be individualized for optimal outcomes, and can better inform clinical decision-making.
We are a well-funded startup, founded in 2015, and headquartered in San Francisco, CA. In response to COVID-19, we have shifted to fully distributed (remote) operations.
We are looking for a Senior Quality Manager to lead quality initiatives for our regulated software products (Software as a Medical Device), including iOS and Android apps and web-based applications. You will manage our design control process and quality management system (QMS) to ensure quality in work processes, products, and services, and facilitate continual improvement. Your success will ensure finished products are safe, effective, and in compliance with Federal regulations. You will ensure test plans are organized, completed, and executed properly. We practice Agile development so you will also perform exploratory testing.
This full-time position reports to the Chief Commercial Officer. This is a remote position and can be located anywhere in the US, though we operate on Pacific Time.
What you will do
- Be responsible for quality assurance and regulatory compliance; continuously improve quality processes and quality systems with the goal of improving patient outcomes, reducing risk, maintaining regulatory compliance, and improving product quality/reliability
- Manage and improve the Quality Management System (QMS)
- Build the trace matrix and execute test plans for each product release
- Ensure design control requirements are implemented and followed; support multiple product development projects and ensure that quality objectives are met during the product development and design transfer life cycle
- Contribute to the preparation of U.S. FDA and global regulatory submissions
- Manage internal and external QA resources
- Organize and run internal testing initiatives
- Perform mobile and web exploratory QA on an on-going basis
What you bring
- 4+ years quality management experience in a medical device (preferred) or pharmaceutical company; experience in mobile and/or web-based QA is a plus
- Experience maintaining and evolving a quality management system (QMS)
- Prior experience managing QA resources
- Excellent communication skills, and experience working in an agile environment
- Project management leadership experience
- Strong critical thinking and decision-making skills
- Ability to work well independently or within a cross-functional team environment
Who you are
- You are fascinated by technology and the way it transforms the way people live and work
- You are always up for a new challenge, not afraid to fail, and insatiably curious
- You are not intimidated by the fast-paced, dynamic characteristics of startups
- You have the intellect to grasp complex ideas
- You are driven by a sense of purpose, and possess the confidence, competence, and willingness to be accountable
- You are a critical thinker, but not critical of others
- You give credit and take responsibility, always defaulting to “we” over “me”
What we offer
We will provide the opportunity to do purposeful work in an ego-free and collaborative team environment. Our culture is infused with passion and purpose, where curiosity is encouraged, conversation is lively and differing opinions are treated with respect. We expect you to make a significant impact.
We also offer:
- Competitive salary
- Stock options
- 401k retirement savings plan
- Flexible vacation
- Parental leave
- Health, dental, and vision
- Health and wellness allowance
- Weekly exercise & meditation classes
- Annual WFH stipend
- Access to our product for family members with qualifying conditions
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