Job Description
The Senior Quality Systems Specialist plays a key role in operating and maintaining our Quality Management System to support the development of digital therapeutics in compliance with international and US medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key software design control, risk management, and change control deliverables for new product development and current on-market products.
The role will partner with cross-functional groups to ensure audit-readiness across the quality management system including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval. Serve as quality team representative to cross functional partners and drive design control activities/deliverables for development and maintenance of SaMD products throughout the Software Device Lifecycle. Facilitate development and maintenance of product design documents including user needs, software requirements specification, design output documents, and design traceability matrices.
About Big Health
At Big Health, our mission is to help millions back to good mental health by providing fully digital, non-drug options for the most common mental health conditions.