Sara Stengel

During my time with THOR Photomedicine, I have expanded the quality system at the UK facility to include the new manufacturing facility in Randolph, Vermont. This has included initiating many new processes and new KPIs. As a medical device company this system is based on several standards including ISO9001, ISO13485, and FDA 820 CFRs. I also manage all CAPAs, nonconformances, equipment calibration, and SCARs related to the NovoTHOR unit and facility. I handle all aspects of the quality system and I am part of the internal auditing team. I'm currently training to be a ISO13485 internal auditor.

Perfectus Biomed was a preclinical contract research organization (CRO) that specialized in custom microbiology projects. This lead a very wide variety of projects and needs. I managed the day to day operations of the laboratory and its technicians and scientists. This included all procurement, scheduling, ensuring timelines were met, training, writing and validating protocols, and managing all equipment and calibration needs. I assigned the scientists their projects, assisted them with their timelines and protocols, and ensured they stayed on track. I had five direct reports including a technician and scientist. I also reported directly to the Chief Scientific Officer.

I also participated in strategic planning for long term growth, managed our budget, initiated and tracked all KPIs. I was able to reduce our consumable of percent revenue from about 30% to less than 12% month over month. I was also able to increase our revenue per scientist over my two years there.

I was also responsible for all aspects of our ISO9001 certified quality system. We were also aiming for two of our internal protocols being ISO17025 accredited. This project was my responsibility and was on its way to being completed on time before the sale to NAMSA.

As quality manager, I was responsible for ensuring compliance with the ISO9001 system. I managed the CAPAs, NCs, Change Control, and Document Control in ETQ Reliance. During my tenor, I assisted in designing and migrating the quality system to ETQ Reliance. I has one direct report.

As the supervisor of the Fill/Finish division, I was responsible for scheduling all client orders, communicating with clients, writing any necessary work instructions, the hands on manufacturing process, and managed all procurement for this division. I also had one direct report.