Montserrat Pou Prats

Quality Management Systems Consultant

FDAAuditingSupplier ManagementQualityPartner🧑‍🔬 Engineer🧨 ConsultingIndustrial EngineerAdvisor

Industrial Engineer graduated from the Santo Domingo Technological Institute (INTEC) with an Executive Master in Integrated Systems Management: Quality, Environment and Occupational Risk Prevention from the School of Industrial Organization (EOI) in Madrid, Spain. Certified Calibration Technician. Six Sigma Green Belt. Certified Lead Auditor in ISO 9001:2015. Internal auditor of quality management systems ISO 9001 and ISO 13485. Certification in Quality Management and Operational Excellence from the American Society of Quality (ASQ CMQ/OE). Certified Auditor of the American Society of Quality (ASQ CQA). Certification as a Supplier Quality Professional (ASQ CSQP). Administration of Management Systems for the regulated medical device industry as a management representative. More than 15 years of experience in internal and third-party audits. Experience in audits of Quality and Environmental Management Systems. Experience in preparing and managing inspections by government institutions (FDA / MISPAS) and certification bodies in ISO standards, as well as compliance audits under the MDSAP (Medical Device Single Audit Program) structure. Experience in Quality Operations Management in the FDA-regulated Medical Device manufacturing industry: manufacturing of sterile medical devices in controlled environments (GMP + BPD / GMP + GDP), implementation of sampling plans, in-process inspection, investigation of non-conformities and root cause determination, release of sterile product, development and implementation of product and process improvement plans and validations. Corrective and preventive actions (Internal and Suppliers), customer complaints, audits of manufacturing processes. Design and improvement of standardized products and processes.

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Network Power<100 people

Roles

🔥50%

Startup Founder

✨50%

Business Owner

🧑‍🔬50%

Engineer

Geos

🇨🇳50%

China

🇩🇴50%

Dominican Republic

Work Background

FreelanceQuality Professional

Oct. 2023Santo Domingo, Dominican Republic · RemoteOpen to support your business achieve its objectives through the implementation and improvement of your Management Systems: Quality, Environmental, Health and Safety. o Consulting in Implementation, Analysis and Improvement of Management Systems - Quality, Safety and Environment. o Training in Quality Topics - CAPA, Audits, Supplier Management, Quality Control, ETAL o Identification of Improvement Opportunities o Audits: Implementation of action plans. o Definition & Improvement of Processes. o Development and Implementation of Management Systems. o Development and implementation of support processes for risk communication to clients. o Development of processes for the implementation of management systems.

MicroPort CRMDirector of Global Quality Engineering and Supplier Quality

Oct. 2022 - Oct. 2023HybridManagement Representative for the QMS three manufacturing sites of MicroPort CRM: o Santo Domingo, DR facility o Saluggia, Italy o Clamart, France Responsible for Product Quality Responsible for the facility Compliance Status Responsible for Product Quality. Responsible for the facility Compliance Status. Development and Monitoring of Key Process Indicators (KPI). Design, development and improvement of management system processes. Support to the improvement of product design and New Product Introduction (NPI). Support to the Design Transfer process. Support to the geographic expansion process and submission of products in new countries. Global responsibility of Supplier Quality Engineering – France, Italy and Dominican Republic o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of supplier quality management system processes. o Management of Supplier-proposed changes.

MicroPort CRMDirector of Global Supplier Quality and DR Quality Engineering

Jan. 2022 - Oct. 2022HybridManagement Representative for the QMS for the Santo Domingo, DR facility o Responsible for Product Quality. o Responsible for the facility Compliance Status. o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of management system processes. o Support to the improvement of product design and New Product Introduction (NPI). o Support to the Design Transfer process. o Support to the geographic expansion process and submission of products in new countries. Global responsibility of Supplier Quality Engineering – France, Italy and Dominican Republic: o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of supplier quality management system processes. o Management of Supplier-proposed changes.

MicroPort CRMSenior Manager - Global Supplier Quality and DR Quality Engineering

May. 2021 - Jan. 2022Management Representative for the QMS for the Santo Domingo, DR facility o Responsible for Product Quality. o Responsible for the facility Compliance Status. o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of management system processes. o Support to the improvement of product design and New Product Introduction (NPI). o Support to the Design Transfer process. o Support to the geographic expansion process and submission of products in new countries. Global responsibility of Supplier Quality Engineering – France, Italy and Dominican Republic o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of supplier quality management system processes. o Management of Supplier-proposed changes.

MicroPort CRMQuality Engineering Manager

Oct. 2019 - Jul. 2021On-siteManagement Representative for the QMS for the Santo Domingo, DR facility: o Responsible for Product Quality. o Responsible for the facility Compliance Status. o Development and Monitoring of Key Process Indicators (KPI). o Design, development and improvement of management system processes. o Support to the improvement of product design and New Product Introduction (NPI). o Support to the Design Transfer process. o Support to the geographic expansion process and submission of products in new countries.

B. Braun Medical Inc. (US)Site Quality Director

Jul. 2018 - Jul. 2019Dominican RepublicManagement Representative for the QMS for the Santo Domingo, DR facility o Responsible for Product Quality o Responsible for the facility Compliance Status o Development and Monitoring of Key Process Indicators (KPI) o Design, development and improvement of management system processes o Responsible for the Management of Raw Material and Critical Services Supplier Quality Management Representative Delegate for preparation and conduction of FDA (Food and Drug Administration) inspection at BBraun Medical, Santo Domingo, RD facility in February 2018. Inspection resulted in no 483. Implementation of Cost of Quality improvement projects.

B. Braun Medical Inc. (US)Interim Quality Director

Aug. 2017 - Jan. 2018Dominican Republic

B. Braun Medical Inc. (US)Quality Control Section Manager

Jul. 2016 - Jul. 2018Dominican RepublicManagement Representative Deputy for the QMS for the Santo Domingo, DR facility Responsible for Product Quality Environmental Monitoring System Administration Non-conforming Product and Process Management System Administration Product and Process Improvement Responsible for the Management of Raw Material and Critical Services Supplier Quality Quality Operative Personnel Supervision: o Environmental Monitoring Laboratory o Incoming Inspection o Print Shop o Assembly/Packaging Quality Inspectors

CareFusionQA Manager

May. 2012 - Jan. 2015Sant Domingo, República DominicanaManagement Representative before the Quality Management System for the Santo Domingo, RD facility. o Responsible for Regulatory Compliance of the Facility: Maintaining healthy regulatory compliance with the Quality Management System for 3 consecutive years as a management representative, through conducting internal audits, supplier management, identifying improvement opportunities and implementing effective action plans; as well as the use of quality tools whose philosophy supports the bases of the PHVA cycle (Plan, Do, Check, Act – Deming Circle) o Lead Auditor for the RD facility, as well as Business Unit - Inter Plants : Creation and execution of programs to adapt successful management systems for audits and follow-up inspections by external organizations. Participation in successful FDA (Food and Drug Administration) inspections resulting in Zero 483. o Responsible for the Facility's Product Quality results: Awarded as part of improvement teams for product redesign, improving product quality and efficiency. o Implementation of the use of predictive indicators of product quality such as: First Pass Yield (FPY), Lot First Pass Yield (LFPY), among others. o Environmental Management System Advisor - ISO 14001 Implementation of the requirements of the Environmental Management System according to ISO 14001:2001. Obtaining certification. o Administration of the operating budget of the Quality area: Reduction of quality costs by 30% in 12 months, through the implementation of sampling plans, validation of test processes, elimination of destructive tests, consolidation of process samples and quality sampling, among other methods.

CareFusionPrincipal Quality Engineer

Sep. 2011 - May. 2012Santo Domingo, Dominican Republico Internal Audit System Administrator o Documentation System Administrator o Training System Administrator o Administrator of the Corrective and Preventive Actions System (CAPA) o Administrator of the Customer Complaints System o Member of the Health, Safety and Environment Committee (EH&S) o Local Contact for Product Registration in International Markets o Lead Auditor - ISO 9001:2008

CareFusionQuality Systems Senior Engineer II

Mar. 2009 - Sep. 2011Santo Domingo, Dominican Republico Administrator of the Internal and Supplier Audit System o Documentation System Administrator o Training System Administrator o Administrator of the Corrective and Preventive Actions System (CAPA) o Administrator of the Customer Complaints System o Environmental Monitoring System Administrator (GMP) o Sterile Product Release System Administrator o Calibration System Administrator o Member of the Health, Safety and Environment Committee (EH&S) o Local Contact for Product Registration in International Markets o Co-leader of transition project due to change of company name o Lead Auditor - ISO 9001:2008

CareFusionQuality Senior Engineer

Apr. 2006 - Mar. 2009Santo Domingo, Dominican Republico Administrator of the External Supplier Management system o Customer complaints system administrator o Internal and external audit system administrator o Redesign of the External Supplier Management and Feedback System o Member of the Health, Safety and Environment Committee (EH&S) o Design changes and product improvements o Participation in FMEAs for the assembly area o Leader auditor

CareFusionQuality Engineer

Nov. 2004 - Apr. 2006Santo Domingo, Dominican Republico Quality Inspector Supervision o ISO 13485:2003 Internal Auditor o Product design changes o Customer complaints system administrator o Administrator of the External Supplier Management system o Redesign of the External Supplier Management and Feedback System o ISO 14001 Internal audits

Cardinal HelathQuality Junior Engineer

Aug. 2003 - Nov. 2004Santo Domingo, Dominican Republic · On-siteo Defect analysis o Implementation of improvements in production lines o Internal audits (ISO 13485) o Customer complaints system administrator o Analysis of customer complaints o Support for the supplier complaints system administrator o Non-conformity management system administrator (NCR) o Administrator of the Corrective and Preventive Actions implementation system (CAPA)

Banco BHD S. A.Project Manager

Mar. 2003 - Jun. 2003Santo Domingo, República Dominicana · On-siteRecruitment and Selection Process Improvement

BAXTER HEALTHCARE PTY LTDProcess Monitoring Intern

Apr. 2002 - Mar. 2003On-siteo Process Audits o Manufacturing Work Instruction Review and Improvement o Support in Inventory Management Projects o Support Scrap Management Projects