Jun 9, 2022
As a Software Quality Assurance Specialist, you will work hands-on to develop and execute our 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.