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Associate Director, Quality Management System

Boston, MA or Remote Considered

Who We Are

PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.


Where You Fit

We're looking for a quality minded professional interested in working in the Software Medical Device industry. As we are expanding our business and products, we are building the quality assurance team. In this role, you have the opportunity to contribute to growing the team and to  developing your own challenging, rewarding career path.


What You’ll Do

If you're the right candidate, you'll be exercising all the skills you have in this role, and building new ones along the way, including:

  • Ensuring that processes needed for the QMS are established, implemented, maintained, & audited. This includes, but is not limited to, Document Control, CAPA, Employee Training, Supplier Management, Customer Complaints, and Design Control.
  • Ensuring the promotion of awareness of customer requirements throughout the organization.
  • Maintaining compliance of the QMS to ISO 13485:2016, 21CFR 820, CAP/CLIA, and GCLP/GCP
  • Reporting to top management on the performance of the QMS & any need for improvement.
  • Ensuring clear, concise, & accurate policies, procedures, instructions, forms, & objectives are provided & maintained.
  • Guide personnel in the correct implementation of the QMS.
  • Monitoring and report on Key Performance Indicators (KPI's). Provide this information on a timely basis so that clear future strategy can be mapped and achieved.
  • Supporting audit activities to ensure compliance
  • Monitoring employee training and documentations to ensure all employees are compliant
  • Training employees on cGMP/13485:2016 requirements
  • Administering the electronic Quality Management System


What You Bring

  • Minimum bachelor’s degree in an appropriate scientific or other related field or four years equivalent relevant experience
  • 10+ years experience in a regulated environment within the Medical Device or pharma industries, implementing, improving, and maintaining a regulated Quality Management System
  • Hands-on ability to work autonomously to problem-solve, demonstrating excellent analytical skills
  • An insatiable intellectual curiosity and the ability to learn quickly in a complex space and help to shape the team
  • Experience with FDA inspections a plus
  • Excellent verbal and oral communication skills

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for. 

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.