About Happify Health
Happify Health is a clinical grade technology company that develops personalized digital therapeutics and care solutions for the modern healthcare cloud.
We are pioneering a new era of care through Intelligent Healing™️ that makes healthcare more precise, connected, and responsive for pharma, health plans, enterprises, and individuals everywhere.
With a foundation in science-backed activities and games, Happify Health was inspired by the idea that technology can be used to incite positive change in our industry—and ourselves. This vision is powered by our growing diverse team of leaders, experts, and creators, collaborating closely to challenge the status quo and redefine our systems of care.
We believe that meaningful behavior change is a journey—and that moving towards better health and well-being should be enjoyable. Together, we can create a healthier, happier future through Intelligent Healing™️.
Join us as we usher in a new era of connected care, and strive to heal all people, one person at a time.
About the Role
As a Software Quality Assurance Specialist, you will work hands-on to develop and execute on Happify’s quality management system while working with Quality Engineers to improve test design and execution in order to achieve high product quality within a medical device regulatory context. #LI-REMOTE
- Assist in establishing, maintaining, overseeing and enforcing all quality assurance standards and programs to assure compliance in accordance with ISO 13485, 21 CFR 820, IEC 62304.
- Initiate, revise and review controlled GMP documentation including procedures and reports.
- Interact with management, peers and partners to assess and improve the adequacy of the QMS processes and procedures.
- Support Employee Quality Training – design and delivery for company wide compliance. Promote a culture of quality.
- Experience applying risk assessment principles according to ISO14971 requirements.
- Participate in nonconformance and CAPA identification, investigation, and resolution.
- Coordination and analysis of QMS metrics.
- Participate in internal and external audits for Happify and conduct third party audits of suppliers.
- Participate in management of LMS/employee training to ensure compliance with SOPs in accordance with relevant regulatory standards.
- Bachelor’s degree and 3+ years of experience in quality, preferably in an agile environment.
- Experience writing and executing manual testing.
- Excellent verbal and written communication skills with the ability to work with cross-departmental functions including regulatory affairs, software developers, department leads, and end users.
- Excellent data collection and analysis skills.
- Experience with software as a medical device (FDA &ISO).
- 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.