ABOUT HAPPIFY HEALTH:
Happify Health is a world leader in the development and delivery of digital mental health solutions, including digital therapeutics. Our platform has been made accessible to over 10 million people and is used by millions.
We are scientists, researchers, health care clinicians, and digital gaming experts passionate about bringing our unique expertise and areas of knowledge together to think differently and to create new highly effective approaches to mental health, making them accessible through technology.
Working closely with health plans, pharmaceutical companies, and self-insured employers, Happify Health uses evidence-based science such as CBT, positive psychology, and mindfulness and combines it with leading-edge, engaging technology to help individuals improve their mental health and wellbeing so they can live life more fully.
ABOUT THE ROLE:
Happify Health is seeking an experienced and dynamic candidate to join our growing team as the Quality Systems Manager (QMS Manager). This candidate will report directly to the VP of Quality and Regulatory Affairs. The QMS Manager will be responsible for maintaining, reporting on and continuously improving the QMS. This position will routinely interact with the clinical team, the operations team, the development team as well as other Happify team members.
***This position would work out of our Boston-area office.*** Some remote work days possible. Travel to conferences and other speaking opportunities is possible. Travel to FDA meetings may be required.
The QMS Manager will be responsible for many different activities to support department and corporate goals. Primary responsibilities for this position are to:
- Ensure compliance with applicable regulations including 21 CFR 820 and ISO 13485
- Manage internal audit program and report on findings
- Revise, write and author policies and procedures as required to maintain compliance to requirements
- Manage the entire QMS including change control, supplier qualifications, training, documentation management, quality agreements, CAPA, investigations, risk management, customer complaints, management review etc.
- Lead and manage strategic QA tasks working with clinical and development teams
- Independently manage projects
- Educate and train team members regarding their impact on quality
- Perform root cause analysis to identify process improvements or resolve identified problems
- Establish and implement metrics to support process improvements and predict trends
- Oversee validation program
- Support interactions with regulatory agencies
- Interact with other team members to share best practices, lessons learned and implementation of improvements
- Other responsibilities as assigned
The ideal candidate should have:
- A minimum of a BA/BS in a scientific discipline with at least 5 years of Medical Device Quality Systems Experience (ideally in digital therapies or software as a medical device)
- Strong knowledge of ISO 13485, IEC 62304, IMDRF SaMD, and 21 CFR 820
- ASQ, CQM, CQE certification preferred
- Excellent communication skills both verbal and written
- Detail oriented, well organized and ability to work across the organization
- The ideal candidate will demonstrate effective problem-solving skills and be proficient in MS Office and Google applications, as well as a general comfort with new technology