STERIS Corporation
As a Lead Quality Specialist in our Sharon Hill, PA location you will be responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions and site record retention.
In addition, the Lead Specialist will lead CAPA and NCR investigations, manage site audit activities, lead audit response development and corrective action tracking, and lead risk management activities where appropriate. This role also analyzes and manages site Quality data.
This position requires working onsite at our Sharon Hill, PA site Monday through Friday during core business hours 8 am to 5 pm and occasional domestic travel up to 10% to our corporate campus in Mentor, OH. What You’ll do as a Lead Quality Specialist Train Quality and Operational staff on Quality policies and work instructions.
Coordinate site audit activities and rec…Quality, Specialist, Lead, Project Management, Benefits, Manufacturing, Technology, Audit