Award-winning, FPX trained Regulatory and Quality Assurance Manager with expertise in all facets of biopharmaceutical and medical device Regulatory, Quality and compliance in major manufacturing facilities. Working knowledge of Quality systems, ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211, 21 CFR 610, regulations document review and approval process, CAPA, non-conformances, regulatory audits, and investigations. Extensive experience in clean room environments, aseptic technique and qualification of cleaning and sterilization equipment. Quality approver and SME for product contamination non-conformances. Strong technical writing skills, mechanical aptitude, and understanding of manufacturing processes.