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 is critical to the success of everything we aspire to do. Our team, comprising diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.
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.
Responsibilities:
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
Requirements:
- 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
Benefits:
For the right candidate, we'll offer a competitive salary plus equity. Your compensation is rounded out by a strong benefits package:
- Flexible work hours, with work-from-home options available
- Three weeks of paid leave per year, an additional two weeks of sick time, plus extended holidays and team-approved leave
- Ten days of 100% subsidized childcare per year
- Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
- Commuter benefit available for public transit or parking
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.
PathAI does not accept unsolicited submissions from third-parties.
With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.