Beata Corral

 Manage all aspects of Cadwell’s Regulatory and Quality Assurance system including direct management of the QA / Regulatory team comprising of five (5) QA/RA engineers
 Develop and maintain quality requirements and standards for the development of medical products, from incoming inspection of supplier material to final inspection of products
 Implementation of ISO standard requirements including ISO 9001, ISO 17025, and ISO 13045, as well as FDA QSR Standard and European Medical Device Directive
 Create and implement process improvement and updates to quality and regulatory department standard operating procedures (SOPs) at medical device manufacturing site
 Identify appropriate standards for application in support of product development and reviewed new regulatory guidance to ensure compliance
 Keep current on all applicable global regulations and changes to those regulations that would affect proposed activities throughout the laboratory and company
 Significant audit experience including internal audits, customer audits, registrar audits, and external audits by regulatory bodies and customers
 Responsible for the planning, preparation, and execution of audits as well as serving as the designated management representative for quality to regulatory agencies
 Conduct Corrective Action / Preventative Action (CA/PA) projects as it relates to internal quality issues, external quality issues, implementing various approaches depending on the potential and/or existing quality issue non-conformance (i.e. 7-step process)
 Manage customer quality complaints as part of external quality issues, conducting CA/PA investigation and follow-up with responsibility for dealing with customer contacts and acting as a first point-of-contact for quality related matters

 Develop and edit technical documents and procedures as part of the implementation of maintenance processes and procedures across Mission Support Alliance facilities
 Ensure compliance with the requirements of the US Department of Energy (DOE), mission support contract, and MSA quality assurance program

 Prepare new laboratory for the process of ISO certification and establish a new QC system
 Draft, prepare, and create necessary SOPs, forms, and other pertinent documents

 Serve as a board member and webmaster / editor for this international organization
 Translate documents, help prepare newsletter, and organize social, cultural, and educational programs for the expatriated community

ensuring product quality and compliance with MLI quality system and ISO requirements
 Ensure consistent application of specifications, procedures, and applicable regulations throughout the company
 Involvement in planning, execution, and follow-up of internal audits, customer audits, registrar body audits, as well as quarterly management reviews
 Responsible for dealing with customer contacts and acting as the first point of contact for quality related matters
 Ensure customer satisfaction initiatives are developed and implemented effectively
 Supervisor the work of other staff members within the Quality Assurance Department
 Report on progress of departmental objectives to the executive team