About this role
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, to maintain compliance and improve efficiency.
- Work cross-functionally to integrate products following corporate and/or product acquisitions.
- Partner with the Quality Assurance team to maintain compliance with applicable US and outside-US standards and regulations.
- Support preparation for and participation in regulatory audits related to design quality and QMS processes as assigned.
- Collect and monitor quality metrics in support of Management Review.
- Identify quality and compliance risks, escalate issues that may affect patient safety or market compliance, and drive corrective and preventive actions to closure.
- Contribute to continuous improvement of design quality and QMS processes, and support development of junior staff as requested.
PLEASE NOTE
This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.