Senior Quality Assurance Specialist

Summary

Join DeepHealth as a Senior Quality Assurance Specialist and support our products and product development, along with the Quality Management System. Collaborate cross-functionally to guide product development and support quality processes such as QMS training, complaint, and CAPA management. Act as the Quality lead for design changes, ensuring compliance with applicable standards. Take ownership of product-specific Quality Management System processes. Integrate products resulting from acquisitions and work with the team to ensure compliance with US and OUS standards. Participate in the development of junior staff and collect/monitor quality metrics.

Requirements

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associate’s degree with 5 years of experience)
• Minimum of 5-8 years (8-10 years preferred) 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
• Excellent written and oral communication skills

Responsibilities

• 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; including the
• 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

Preferred Qualifications

• 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

Benefits

• This position may be based in the United States or India 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