Job purpose The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Principal will be responsible for collaborating cross-functionally to support and guide product development. The Quality Assurance Principal will work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management. Duties and responsibilities As the Quality Assurance Principal, this position will: Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the 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, to ensure compliance with the applicable standards and guidances. Guide junior Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management. Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency. Work cross-functionally to integrate products as a result of corporate and/or product acquisitions. Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations. Participate in the development of junior staff, as requested Collect/monitor quality metrics in support of Management Review 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. Qualifications Qualifications include: Bachelor’s degree in relevant field (or equivalent experience, i.e. Associate’s degree with 5 years of experience). Minimum of 8-10 working in a regulated industry (FDA and Software as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred. Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required. Participation in regulatory audits a plus Excellent written and oral communication skills Working conditions This position may be based in the United States or the European Union (preferred) in a typical office setting. This position will have the ability to work remotely and may require a flexible work schedule in order to support international teams. Physical requirements This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.
**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.,