Sandra Perez
Capa Manager @Beckman Coulter Diagnostics
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WORK HISTORY
Capa Manager @Beckman Coulter Diagnostics
Brea, CA, US
Manage Chemistry and Immunoassay business unit CAPAs in the US and Asia Pacific including China and Japan as well as commercial distribution site in the US. Responsible for managing 4 CAPA Review Boards and managing a large portfolio of CAPAs. Lead CRB discussions in biweekly meetings. Ensure adequacy in CAPA documentation and compliance to CAPA regulations. Supported sites for reinspection preparedness with a successful reinspection and zero findings on the CAPA process. Manage KPIs and metric reporting for CAPA process.
EDUCATION
California State University, Northridge
Bachelor's of Science (BS), Health Science-Public Health
Simi Institute
Certified Respiratory Care Practitioner, CRTT, RCP
Los Angeles Mission College
Associate of Science - AS, Health Services/Allied Health/Health Sciences
SKILLS
ABOUT SANDRA PEREZ
Over 25-year work experience in the medical device, hospital and healthcare field with management experience, working in Sales, Quality Assurance, and Clinical areas in Diabetes Care, Respiratory care, Cardiac Rhythm Management, Neuromodulation, Diagnostics, and Chemistry & Immunoassay. Quality professional working directly with medical devices, Global Quality systems, and engineering, ensuring regulatory compliance to FDA and other Regulatory agencies. 5+ years of clinical work experience as a state licensed Respiratory Care Practitioner providing one on one patient care.
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