Jeffrey Monroe
Director, Quality Assurance at Henry Schein Orthodontics
Based in San Diego County, United States
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Seniority
Director
Department
Information Technology
Location
San Diego County
Industry
Medical Equipment Manufacturing
Company size
136
Contact information
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j•••••••@henryscheinortho.com
Phone
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Background
About Jeffrey Monroe
I am a Quality Systems professional with a track record of successfully developing and monitoring compliant quality system processes, implementing and training on Quality Management System software applications and taking on multiple new project assignments which are completed on time. Specialties- Complaint Handling & Reporting - Corrective Action Preventive Action (CAPA)- Nonconforming Material Reporting (NCMR)- Post Market Surveillance - Quality System Metrics & Analytics - FDA/Medical Device - Quality System Development - Quality Management Systems (21 CFR 820 & 803, ISO 13485:2016)- Cost of Poor Quality program - MDSAP Single Audit Program - Global Compliance Leader (CAPA, Complaints, Vigilance)- Unique Device Identification (UDI)- MDD, MEDDEV, Vigilance & MDR - Audit Program Additionally responsible for ensuring compliance to domestic and international standards and requirements: ISO 9001, ISO 13485-2016, 21 CFR Parts 820, 803 & 806, MDSAP, MDR & UDI
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