About Happify Health
Happify Health is a LifeTech company whose mission is to improve access to mental, physical and chronic care through a single digital self-care platform while driving mass-market adoption of Digital Therapeutics. We are a collective of scientists, researchers, clinicians, content creators and AI engineers united to solve some of humanity’s greatest health challenges. Our clinically-validated platform provides global access to one of the most comprehensive, evidence-based intervention catalogs available, resulting in better health and business outcomes for people and organizations.
About the Role
Happify Health is hiring an experienced and dynamic candidate to join our growing team as the Quality Management System (QMS) Manager. Reporting directly to the Director of Quality Systems, you will be responsible for maintaining, reporting on, and continuously improving the QMS. You’ll work closely with teams across Happify - from the business units, to the clinical team, the operations team, and the development team.
- Ensure compliance with applicable regulations including IEC 62304, 21 CFR 820 , MDSAP and ISO 13485.
- Manage internal audit programs and report on findings.
- Revise, write, and author policies and procedures 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.
- Educate and train team members regarding their impact on quality.
- Establish and implement metrics to support process improvements and predict trends.
- A BA/BS in a scientific discipline.
- Proven success in a role focused on Software as a Medical Device (SaMD) Quality Systems; experience in digital therapeutics is an asset.
- Strong knowledge of ISO 13485, IEC 62304, IMDRF SaMD, MDSAP and 21 CFR 820.
- ASQ, CQM, CQE certification is preferred.
- Excellent communication skills.
- Ability to thrive in a fast-paced, technical, and mission-focused environment.
Happify values candidates with different backgrounds, experiences, and perspectives. We do not discriminate based upon ethnicity, age, gender identity and expression, sexual orientation, religion, national origin, socioeconomic status, disability, or veteran status. We're committed to building a company that is an inclusive environment for all.
There have been cases of scams targeting candidates by individuals pretending to work at Happify. We will never ask you to share financial information to participate in our recruiting process. If you suspect that you've been contacted by a scammer, please consider filing a report with law enforcement. If you'd like to verify an email you received from Happify, please write us at email@example.com.