Beatriz Castro-Nelson's Email Addresses & Phone Numbers

Quality Manager, Complaint Handling @  Manage through subordinates the investigation and processing complaint cycle time reduction, while maintaining compliance to all regulations.  Accountable for department compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance...

Quality Manager, Complaint Handling @  Manage through subordinates the investigation and processing complaint cycle time reduction, while maintaining compliance to all regulations.  Accountable for department compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV).  Direct System Administrator with worldwide system optimizations and operations.  Represent Complaint Handling & Safety Surveillance department during Internal & External audits.  Manage directly, or through subordinates, Complaint Handling activities, such as ensuring timely and accurate product complaint capture, reporting, and customer communication and complaint closure.  Responsible for the overall direction, coordination, structure, and evaluation of the Complaint Handling Specialists and System Administrator.  Plans, promotes, and organizes training activities related to product quality, and regulatory compliance.  Manage complaint handling activities of global OUS Quality and Regulatory Affairs Personnel From November 2008 to Present (7 years 2 months) WW Quality Systems Manager – CAPA, Nonconformance and Management Review @  Responsible for the management of the Worldwide CAPA and Nonconformance (NC) Processes and Systems.  Manage and coordinated the work of Quality Engineers.  Assured the accountability for nonconformance resolution and effectiveness.  Responsible for the integration of CAPA with other Quality Systems.  Participated as a key member in both internal and external audits (FDA, BSI, TGA, PMDA) for CAPA and NC.  Provided guidance in the management of corrective and preventive action prioritization and resolution.  Responsible for the Management Review Process (process improvements and deployment).  Reviewed and approved Multi-Site CAPA action plans.  Provided input into new software acquisitions (process & system training, software implementation). From March 2006 to November 2008 (2 years 9 months) Sr. Quality Engineer, WW CAPA System Improvement, Software Support and Training @ From February 2005 to March 2006 (1 year 2 months) Software Quality Engineer @  Provided software quality engineering principle expertise, both external (Regulations) and internal (company procedures).  Provided training to software development teams, staff, contractors and business partners on software quality engineering procedures.  Provided support on projects. Assured compliance with procedures, identified task dependencies, guided teams on appropriateness of the development life cycle, and assured development and maintenance efforts were effective and compliant.  Continually improved the software quality engineering processes.  Interfaced with Engineering and IT to determine the required content and breadth of pre-validation activities that support successful product validation upon project implementation.  Provided software quality engineering guidance and related regulatory expertise to project teams. Reviewed software project deliverables.  Performed audits of internal software development projects and external providers of software or services. From June 1999 to February 2005 (5 years 9 months) Master of Science (MS), Software Engineering @ National University From 1998 to 2000 BS, Biology @ Universidad Interamericana From 1990 to 1994 Beatriz Castro-Nelson is skilled in: Medical Devices, Quality System, FDA, V&V, Quality Assurance, ISO 13485, CAPA, Complaint Management, ISO 14971, Validation, Process Improvement, GMP, Quality Auditing, Change Control, Quality Control, DMAIC, Design Control, 21 CFR, Regulatory Affairs