Quality Assurance Specialist, Software (Digital Health)August 30, 2021 2021-09-02 19:40
About Happify Health
Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people. The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.
Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.
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.
- Maintain quality assurance and design control documentation with relevant stakeholders.
- 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.
To apply for this job please visit boards.greenhouse.io.