Quality Assurance Specialist

Job Summary

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.

Essential 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.

Minimum Qualifications Education and Experience

• Bachelors degree in relevant field (or equivalent experience i.e. Associates degree with 5 years of experience).

• Minimum of -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

Physical Demands

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.

Working Environment

Remote. This position requires domestic / international travel up to 15%.

ACCOMMODATIONS
Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

Notice for New York City Applicants:
For roles based in New York City RadNet/DeepHealth may use an Automated Employment Decision Tool (AEDT) to assist in candidate assessment. New York City residents may review the required AEDT notice bias audit summary and information on how to request an alternative process by contacting