Experienced and enthusiastic multilingual professional with a strong background in Business Operations, HR, Supply Chain, Retail and Change Management.
I have successfully led multiple teams as a Director and VP in the hardware retail industry in the Dominican Republic, driving operational excellence and delivering exceptional results. I have also leveraged my diverse skill set as a Business Development and Customer Success Manager in the food tech industry in New York City, where I collaborated closely with clients to ensure their success and maximize their satisfaction. Currently, I am freelancing as a Senior AI Writer of LLMs for Outlier AI.
With fluency in multiple languages, I excel in fostering cross-cultural communication and building strong relationships with diverse stakeholders. I am passionate about driving organizational growth, optimizing processes, and enhancing customer experiences.More...
Montserrat Pou Prats
Quality Management Systems Consultant
Verified
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.More...