Sofía Acevedo Alvarez Email & Phone Number

Provision of services to medical business in EU, US and Asia with respect to Quality Systems Management, Audit Management, Process Engineering Solutions and Training in IVD and Medical Device (Class I, IIa, IIb and III).Specialties:o Quality Systems: ISO13485 & ISO9001 Implementation.o New Product Development: Design Controls Implementation.o Risk Management Process Implementation (ISO14971). Risk Assessment Facilitator. o Software Validation - CSV.o Process Validation. o Design For Six Sigma. Problem solving.o Preparation of Technical Files for EU and FDA submissions.o Audit Preparation / FDA, ANVISA Audit Preparation. Supplier Assessments.o Training.: Risk Management / Managing Requirements / Process Validation / Design Controls / CAPA / GMP - GLP

Swansea, United Kingdom

United Kingdom

Southampton, United Kingdom

Swansea, United Kingdom

Implementation of Quality Management System against ISO 13485 Medical Devices and to be compliant with the following regulations and standards:o Medical Device Directive 93/42/EECo CFR, title 21, Food & Drugs 21 CFR 820, Quality System Regulationo Active Implantable Medical Device Directive 90/385/EEC

Bristol

Quality Management System development and implementation. Design Controls, Risk Management and CE mark for new diagnostic imaging systems.Achievements: Certification of the QMS according ISO 13485.CE marking for MARIA system, Class IIa device.

Manchester

GLP Implementation.New Product Design & Development Champion.Risk Management Champion.Applied to therapeutic drug monitoring kits and consumables for mass spectrometry and liquid chromatography.

Cardiff

I’m actively involved in boosting the continuous improvement of the New Product Development Process in order to deliver compliant and high quality products in order to facilitate all the stages of the development process until product launch. Re-design of the Design Control procedure in order to provide a user friendly approach that it is not simple but understandable. Compilation of Technical files for Regulatory submissions included 510(K) clearance.Re-design the Risk Management process to be compliant against ISO 14971.o ANVISA Audit. March 2011. o FDA Audit. August 2010.o Development and launch of Gynecare Versapoint II – Hysteroscopic Bipolar Electrosurgical System. Quality Plan; Validation Master Plan; Software Validation; Risk Management – Software Risk Analysis; Essential Requirements Checklist; Technical File.o Design Inputs procedure revised and updated. Product Requirements Specifications and Design Specifications. o Implementation of the Deviation Procedure. o Software Development Life Cycle Process compliant against IEC62304 Review. CVS Registration Form.o Risk Management Process: Current assignment.o Design and Development of New Product: Current assignment for two projects.o CAPA Management. o Training: Risk Management / Managing Requirements / GMP / Deviations.o Mexico – Saltillo facility support. Validation / CAPA / Recall.o China – LHI. Strategy change and Implementation of continuous improvement program / Validation / CAPA / Training.

o Quality System Designer/Developer and Implementer. SPD quality system accredited in November 2008. (SPD was formed in 2007).o Facilitator and Advisor to the project teams on all procedural matters affecting the delivery of a compliant design (with regards to legislation and the SPD Quality Management System) by providing leadership, direction and design control expertise.o Project Management - Definition of Quality objectives for new projects. - Write and develop Project Plans and Validation Master Plans.- Guidelines on Device History Files and Technical Files for submissions.- System Risk Analysis. Identification of hazards (FMEA).- Design and develop of verification and validation requirements.- Clinical trials.- Design Transfer and work with process manufacturing teams.o Coach/Trainer – Delivering training to individuals and groups on risk management, managing requirements, design verification, design validation, design controls. o Executing Audits and Supplier assessments. (Chinese and Polish subcontractors)o Managing Deviations, Non-conformances and CAPA.o Reviewed documents throughout the life cycle of product development to ensure compliance with regulations and the SPD Quality Management System. o Project Management Processes and Requirements.o Retrospective validation. o Equipment qualification.o Proactively communicated the importance of quality and compliance throughout the organization. Raised the QA culture across the organization.o Advised and encouraged others on how to meet the quality objectives using quality methods in their ways of working.

- Reporting to the QA Manager on all aspects of Document Control and product release at BBI in accordance with ISO 9001:2000, ISO 13485:2003 and GMP guidelines.- Process reengineering in order to develop an efficient process for the main products manufactured at BBI.- Process improvement: Reviewing and updating procedures in order to simplify and clarify them through flow charts, diagrams and process maps.- Supported and advised all departments in QA related matters.- Complaint Management.- Performing of Internal Audits.- CAPA meetings. Logging of all Deviations and NC, facilitating closure of them and maintenance of deviation register.- Review, approval and maintenance of batch records and Device History Files in accordance with defined procedures. Batch release.- Draft for the Quality Policy. Draft for the new Quality Manual. I turned the old QM into a leaflet of 3 pages.- Reporting to the QA Director and the Managing Director the all aspects of the Indicators in order to asses the Quality Objectives. Write of reports and presentations in power point.- Conduct ISO, Quality and Basic GMP Induction Training.

Certification of the laboratory (FJD-UNILABS, Madrid) on ISO 9001:2000 in June 2005 (Haematology, Immunology, Biochemistry and Microbiology areas). Implementation of the System for the certification of the rest of the laboratory. CAPA system: Study and follow-up of the corrective actions until its closure. Complaints. Documentation control: examination, review, update and distribution. Performance of Internal Audits. Training personnel. Check of calibrations. Project Quality Manager of Laboratories of Clinical Tests:- Hospital La Zarzuela, Madrid.- Hospital Virgen del Mar, Madrid.- Hospital Nuestra Señora de América, Madrid.

Education record

Risk Management

October 2009

Six Sigma Green Belt

Lead Auditor

Recognized by the British Institute for Quality Assurance (I.Q.A)

Education record