Quality Assurance Principal

**Job Description:** As the Quality Assurance Principal at DeepHealth, you will play a crucial role in supporting the company's products and product development processes. You will collaborate cross-functionally to guide product development, ensure quality processes are in place, and maintain compliance with relevant standards and regulations. **Key Responsibilities:** - Actively engage with Engineering, Clinical, and Marketing teams to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes. - Lead quality initiatives for design changes to existing DeepHealth products, ensuring compliance with applicable standards. - Mentor junior Quality Assurance team members to ensure consistent implementation of quality processes, including design control and risk management. - Take charge of product-specific Quality Management System processes such as CAPAs and complaint management to drive efficiency and compliance. - Collaborate across functions to integrate products resulting from corporate or product acquisitions. - Work alongside the Quality Assurance team to ensure compliance with US and OUS standards and regulations. - Participate in the development of junior staff as required. - Collect and monitor quality metrics to support Management Review. **Qualifications:** - Bachelor's degree in a relevant field or equivalent experience (e.g., Associates degree with 5 years of experience). - Minimum of 8-10 years of experience in a regulated industry, with preference for FDA and Software as a Medical Device background. - Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820. - Familiarity with EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 is preferred. - Understanding of pre- and post-market clinical studies, including 21 CFR 812, 21 CFR 50, and 21 CFR 56, is advantageous. - Experience in participation in regulatory audits is a plus. - Excellent written and oral communication skills. **Additional Details:** This position may be based in the United States or the European Union, with a preference for the latter, in a typical office setting. The role offers the flexibility to work remotely and may require a flexible schedule to support international teams. This position involves various physical requirements such as sitting, standing, walking, bending, and lifting up to 10 pounds occasionally. Additionally, travel (~10% of the time) and the use of different transportation modes may be necessary.,