Jeffrey Monroe
Director of Quality Assurance at Henry Schein Ortho
- Role
- Director, Quality Assurance at Henry Schein Orthodontics
- Location
- San Diego County, CA, US
- LinkedIn followers
- 500 followers
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 13•••••16, 21 CFR Parts 820, 803 & 806, MDSAP, MDR & UDI
Experience
Director, Quality Assurance
Apr 2022 — Present · Carlsbad, CA, US
Education
California State Polytechnic University-Pomona
Bachelor of Science - BS, Business Administration
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