Sr. Specialist, Quality Systems
San Francisco /
Regulatory Affairs & Quality /
Big Health is a mission driven organization committed to bringing millions of people back to good mental health.
Today, over 12 million people worldwide have reimbursed access to Big Health’s products, via leading employers in the US and the UK’s NHS.
Our digital therapeutics - Daylight™ for worry and anxiety - and Sleepio™ for poor sleep - are fully automated cognitive and behavioral programs that are as scalable and clinically validated as drugs (including being backed by 50 published clinical papers including 13 randomized controlled trials).
Our software combines the intimacy of the human voice, engaging animation, and clinically rigorous techniques to help people overcome their mental health challenges.
We are hiring a Quality Specialist. To provide on-going, day-to-day support for the Quality Management System. This includes assisting with a variety of internal quality system implementation and improvement projects supporting the Quality team, improving and executing policies and procedures to ensure processes meet global standards, and interacting with cross functional teams, including Regulatory Affairs, Product Development, User Happiness, and Clinical Affairs.
As the Sr. Specialist, Quality Systems at Big Health, you will:
- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Execute QMS activities with defined scope and complexity, in areas including design control activities, external audit support; training development and management; and parts and BOM generation and maintenance.
- Provide project management support for QMS related activities.
- Support CAPA investigations and corrective actions and effectiveness checks process.
- Participate in interdepartmental initiatives for continuous improvement. Support continuous improvement of quality system processes and procedures, including developing and maintaining Standard Operating Procedures (SOPs).
- Provide guidance on general quality principles and procedural requirements.
- Perform and complete work with a moderate degree of supervision. Recognize and provide solutions to atypical or infrequent issues based on the defined internal procedures.
- Participate in the internal audit program, as needed.
In order to be successful in this role, you will need:
- 5+ years of Quality Management experience (system & design) in medical devices.
- BA/BS degree in a technical field or equivalent practical experience.
- Familiarity with standards and regulations such as ISO 13485 and FDA Quality System regulations etc.
- Previous experience supporting significant portions 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.
Because we are on a mission to bring millions back to good mental health, we believe it’s essential 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. Big Health participates in E-Verify and will provide the federal government with Form I-9 information from all new employees to confirm that they are authorized to work in the U.S. Big Health does not use E-Verify to pre-screen applicants.