Luis Eduardo Portillo Esquivel

Senior Quality Assurance Engineer, Validation @STEMCELL Technologies

Vancouver, BC, CA

Apply the Risk Management program per ISO14971 with applied statistical techniques.• Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive continuous improvement. • Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate acceptability of the developed formulation and process.• Prepare, review and/or coordinate the execution of validation, commissioning and qualification documentation (IOPQ).• Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device and/or biopharmaceutical regulations and products (ISO13485 & cGMP).• Work cross functionally with other groups to establish a program to collect and analyze product and process data to evaluate the state of control of the process/es.• Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas.• Quality Assurance Lead in the Transfer to Operations (TTO) of equipment from one manufacturing facility into another oner.