Director – Quality Assurance
Biopharma Lab
Posted on 7/19/2023
INACTIVE
PathAI

201-500 employees

AI-powered technology for pathology
Company Overview
PathAI is dedicated to improving patient outcomes with reliable AI-Powered technology and meaningful collaboration with biopharma, laboratories, and clinicians — aiming to provide patients with access to accurate diagnoses and effective treatments.
Locations
Memphis, TN, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
  • Minimum 10 years' experience in medical device, IVD, or biotechnology
  • Preferred minimum 7 years experience in Quality Management System
  • Bachelor's degree required
  • Scientific problem-solving skills using industry accepted tools
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication
  • Capability to interact with diplomacy and tact while maintaining appropriate assertiveness
  • Demonstrated ability to communicate effectively both verbally and in writing
  • Must be detail oriented, well organized, and able to work independently and in teams
  • Knowledge of CAP/CLIA and GCP/GCLP preferred
Responsibilities
  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
  • Manages the QA team and oversee daily QA operations
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
  • Prepares reports and/or necessary documentation (such as Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
  • Maintains a state of inspection readiness
  • Participates in other duties as needed
  • Implementation of CAP/CLIA and GCP/GCLP