PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Rigorous science and careful analysis are critical to the success of everything we aspire to do. Our team, composed of diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.
We are searching for a talented Director of Quality to lead the Quality Department for our newly acquired PathAI Diagnostics Division. This individual will report directly to the President of PathAI Diagnostics. The ideal candidate is someone who has deep expertise in Quality Assurance in the Diagnostic space and is ready to apply their skill set in a fast-paced and growing company and is excited to shape the new category of AI-powered pathology.
- Lead and manage all elements of CAP, CLIA, and other regulatory institution requirements; oversee the Quality Management Program for the entire laboratory
- Maintain lab licensing for various states
- Create daily and monthly metrics reports, and organize monthly QA meetings for each division
- Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
- Delegate and/or write and update all SOPs for all divisions; Annually review SOPs and update as necessary
- Organize initial and ongoing training for all employees of the laboratory; Maintain employee files and create new employee files documenting training, evaluations, CME, etc
- Ensure all laboratory records are maintained, completed, and available upon inspection by representatives from state, federal, and accrediting agencies as required by industry regulations
- Administer or make available monthly CME for all lab employees to satisfy industry requirements
- Create validation documents for all new equipment and processes; Ensure maintenance and QC for all lab equipment
- Manage the design, collection, approval and filing of all QC log documents in the laboratory
- Work with the lab director to develop and maintain a quality assurance plan for each division
- Work with the lab operations team to improve workflow, procedures and processes
- Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner while maintaining adherence to all regulations
- Partner with clinical and compliance to ensure cross-departmental QA alignment
- Promote our culture of performance and improvement
- BS Degree in a scientific field. Advanced degree preferred but not required.
- 12-15 years of relevant experience in the diagnostics, medical device, digital health, or biotechnology/pharmaceutical industry
- Minimum 5 years of proven direct leadership experience in the Quality profession
- Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards and demonstrated implementation
- Previous experience with building QA systems and company-wide SOP systems
- Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
- Strong knowledge and experience with relevant electronic quality management systems
- Excellent written and verbal communication skills
- Strong desire and demonstrated experience with cross-functional communication and internal/external stakeholder management
PathAI Diagnostics offers a wide range of benefits including (but not limited to):
- Healthcare, vision, and dental healthcare plans, with add-ons for life and disability insurance
- 401(k) retirement plan
- Three weeks of PTO per year, plus six paid holidays
Most importantly, you'll be doing important work with a team of people you'll genuinely enjoy spending the day with.
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