Quality Specialist

Job description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary: The Quality Specialist is 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 coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process. What You'll Do as a Quality Specialist The Experience, Skills and Abilities Needed Required: - Complete document control transactions. - Manage Customer complaint investigations and complete complaint documentation. - Facilitate CAPA and NCR investigations and may coordinate investigation documentation. - Review DHR’s and support batch record re...