The Senior Quality Systems Specialist will manage quality systems for digital therapeutics, ensuring compliance with regulations and driving product quality and improvement through audits and documentation support.
Our Mission
At Big Health, our mission is to help millions back to good mental health by providing fully digital, non-drug options for the most common mental health conditions. Our digital therapeutics—SleepioRx for insomnia and DaylightRx for anxiety, both recently cleared by the FDA—provide treatment anytime, anywhere. Our digital program, Spark Direct, helps to reduce the impact of persistent depressive symptoms.
In pursuit of our mission, we’ve pioneered the first at-scale digital therapeutic business model, in partnership with some of the most prominent global healthcare organizations, including leading Fortune 500 healthcare companies and Scotland’s NHS. Through product innovation, robust clinical evaluation, and a commitment to equity at scale, we are designing the next generation of medicine and the future of mental health care.
Our Vision
Over the next 5-10 years, we believe digital therapeutics (DTx) will transform the delivery of health care worldwide, providing access to safe and effective evidence-based treatments to billions. Big Health is in a prime position to take the lead in this transformation.
Big Health is a remote-first company, and this role can be based anywhere in the US. We encourage you to apply even if you don’t meet 100% of the job requirements.
Join Us
The Senior Quality Systems Specialist plays a key role in operating and maintaining our Quality Management System to support the development of digital therapeutics in compliance with international and US medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key software design control, risk management, and change control deliverables for new product development and current on-market products. The role will partner with cross-functional groups to ensure audit-readiness across the quality management system including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval.
Responsibilities
- Serve as quality team representative to cross functional partners and drive design control activities/deliverables for development and maintenance of SaMD products throughout the Software Device Lifecycle.
- Facilitate development and maintenance of product design documents including user needs, software requirements specification, design output documents, and design traceability matrices.
- Support risk management activities to maintain a comprehensive product risk management file including product hazard analysis/FMEA, use error analysis and risk management report.
- Lead quality system related activities and processes per ISO 13485, including complaint handling, CAPA investigation and supplier evaluations, training development and management, etc. to ensure product quality and proper implementation of compliant processes.
- Collaborate with internal teams to identify and implement improvements to quality management processes and ensure internal SOPs are compliant with applicable international and local regulations.
- Participate in the internal and external audit program as needed.
- Identify and drive resolution of quality system issues, ensuring alignment with internal procedures and continuous improvement best practices.
- Provide Document Control support to ensure all big health records and documents are captured within the internal eQMS system.
Required Skills and Experience
- A minimum of 3 years of Quality Management experience (system & design) in medical devices.
- Working knowledge of Quality Systems in compliance with national and international regulations including 21 CFR 820, ISO 13485, ISO 14971, EU Medical Device Regulations, and IEC 62304.
- Working knowledge of software development tools and processes. Including a good understanding of how Agile Software Development practices work with the FDA Quality System Regulation and ISO 13485 Requirements.
- Previous experience supporting significant portions of a medical device quality system and demonstrated use of quality tools/methodologies.
- Previous experience in software as a medical device preferred.Cross-functional/cross-divisional experience and clear, concise communication skills.
- An interest in healthcare and wellness and a passion for directly improving people’s lives.
- BA/BS degree in a technical field or equivalent practical experience.
Background and Life at Big Health
- Backed by leading venture capital firms, Index Ventures, Octopus Ventures, and Kaiser Permanente Ventures
- 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
- Surround yourself with the smartest, most enthusiastic, and most dedicated people you'll ever meet—people who listen well, learn from their mistakes, and when things go wrong, generously pull together to help each other out. Having a bigger heart and a small ego are central to our values
- Enjoy benefits including a generous vacation policy, professional development fund, flexible working arrangements, and more
- Competitive salary packages including stock options
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.
Top Skills
21 Cfr 820
Agile Software Development
Eqms
Iec 62304
Iso 13485
Iso 14971
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