Quality Assurance Principal

The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, and for Quality Management System effectiveness across the organization. This individual contributor role leads design-quality and product lifecycle quality work, owns assigned QMS processes such as CAPA and complaint management, guides junior Quality Assurance team members, and partners with Engineering, Clinical, Marketing, and QRC colleagues to maintain compliance with applicable US and outside-US standards and regulations.

Essential Duties and Responsibilities 

• Engage cross-functionally with Engineering, Clinical, Marketing, and other partners to support new product development through Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.

• Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, so changes remain compliant with applicable standards and guidance.

• Guide junior Quality Assurance team members on consistent implementation of quality processes, including design control and risk management.

• Own assigned product-related Quality Management System processes, such as CAPA and complaint management