Director of Quality Assurance - Needham, MA - Remote

Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis’ connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Needham, MA and key offices in Singapore and India. Join our team -  we are Committed, Collaborative and Curious….we are Biofourmis!

The Director of Quality Assurance is responsible for developing and implementing the long range regulatory compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis business strategy. This role will report to the Sr. VP of Q&R and will have responsibility for the following customer based solutions globally marketed;

• Establishing and maintaining a product compliance strategy for products that are offered in geographies such as the US, EU, and Asian markets
• Ensuring consistency and delivery of product and services within the implemented market requirements
• Managing, reviewing, and overseeing the design assurance aspects of product specifications prior to market launch and implementation
• Establishing and overseeing key compliance processes that require timely and effective execution utilizing key indicators and process improvement techniques
• Supporting and guiding product development and manufacturing teams to ensure compliance to applicable requirements and regulations
• Leading the Biofourmis Quality System by championing and /or …