Job description
Description
The Senior Quality Assurance Specialist is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Sr. Quality Assurance Specialist will be responsible for collaborating cross-functionally to support and guide product development. The Sr. Quality Assurance Specialist will work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management.
Requirements
As the Sr. Quality Assurance Specialist, 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; 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
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 include:
● 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.
● 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 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.
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.
