Beth Casler

I have always had a love for science! Due to my love of science, I naturally steered my educational focus in a science-based programs where I also experienced a Co-Op position with a local hospital as a laboratory assistant and learned phlebotomy, hematology and serology test methods. Later I transitioned my studies to a focus on biology, biochemistry and applied immunology. I am still learning every day!I worked in local hospitals as a Laboratory Assistant, Phlebotomists and Histology Assistant and then in Food Quality Assurance/Control for several years which included working with Good Laboratory Practices and HAACP. I initially transitioned into medical devices when I was hired by a medical device manufacturing company with a goal to update their FDA QSR system to ISO9000 QMS and obtain ISO certification. I continued down this path and over the last 20+ years I have worked in Quality Assurance, Quality Control and Regulatory Affairs in the Medical Device industry. As I work for a small medical device manufacturer, the benefit was I had to wear many ‘hats’ and acquired a lot of ‘hands on’ experiences, including the areas below:• Medical device registrations; both U.S. and International• Quality Management Systems (ISO 13485, ISO 9000)• Medical Device Reporting (MDR)• Post-Market Surveillance (PMS)• U.S. Importation Requirements (HTS)• Training company personnel to Quality and Regulatory requirements• Internal Auditor (Lead Auditor ISO 13485:2016)• Supplier Auditor • Sterilization Program Management (ISO 11135, ISO 11137)• Biocompatibility Evaluations (ISO 10993)• Risk Management Programs (ISO 14971)• Design Team; product development and design changes • Supply Chain Evaluations; for regulatory requirements (REACH, Prop65, Conflict Minerals, etc.)• Safety Programs (OSHA)Currently, my job responsibilities are focused in Regulatory areas and as a leader of the company Risk Management Teams. I continue to support in other areas, such as Internal Audits, Supplier Audits, Supplier Evaluations and other areas, as needed.