ABOUT UNLEARN
Recent progress in artificial intelligence coupled with a growing resource of longitudinal patient data from historical clinical trials and real world sources provides an unprecedented opportunity to transform clinical trials and speed the development of new medicines.
Unlearn is a science-first company that has invented the first machine learning platform for creating Digital Twins of patients in clinical trials — comprehensive simulations that answer “what would likely happen to this patient if he/she were randomized to the control group?”.
Using information from Digital Twins to estimate treatment effects reduces required sample sizes, increase statistical power, and provides patient-level treatment response information.
It's about increasing confidence in trial results.
It's about bringing new medicines to patients faster.
It's about time.
YOUR ROLE AT UNLEARN
You will be responsible for leading Quality Management System (QMS) implementation activities and for assuring compliance as set forth by regulatory guidelines and our QMS. You will work cross functionally to draft templates, Standard Operating Procedures (SOPs), design control files and other documents, and ensure compliance. As Unlearn's first QA specialist you will lead the implementation of our QMS, a key contribution to the company.
Role Responsibilities:
- Perform development and revision of Controlled documents such as Standard Operating Procedures (SOPs), Policies and related documentation.
- Perform Quality Management System documentation, Quality Control reviews, and provides feedback to key stakeholders as needed.
- Conduct internal audits, assist in external audits related activities, and perform timely follow ups on Corrective Action/Preventive Actions.
- Work closely with internal departments to assure compliance with quality systems and related regulations.
- Prepare quality and compliance training materials and delivers company-wide training.
- Represent Quality Assurance on cross functional project teams as required.
YOUR QUALIFICATIONS
- Minimum of a Bachelor of Science Degree in Engineering or scientific field with at least 5 years in Quality assurance in the medical device industry.
- Certification in Quality Assurance or Regulatory Affairs preferred (ISO 13485, ISO 127001, ASQ-CQA)
- Working knowledge and understanding of Medical Device regulations and standards such as 21CFR 820, 21CFR Part 11, ISO 13485 and Risk Management (ISO 14971)
- Experience in developing SOPs for quality assurance and compliance
- Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented.
- Demonstrated ability to work in a fast-paced, cross-functional team environment.
COMPENSATION & BENEFITS
Unlearn offers compensation commensurate with experience as well as a competitive benefits package, including:
- Generous equity participation.
- Unlimited PTO plus company holidays.
- Annual company-wide shutdown between Christmas and New Years holidays.
- Professional development budget to attend conferences or other events.
- 401k plan with generous matching.
- Company-subsidized medical, dental, & vision insurance plans.
- Commuter benefits plan.
- Paid Parental Leave
Unlearn is not currently offering visa sponsorships for any position. Please only apply if authorized to work in the U.S.