The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities: -- Data Gathering-Participate in the discovery and compilation of required documentation to be evaluated. -- Gap Assessments-Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.--Remediation Plan - Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, etc.)
Requisitos:
BS in Engineering or Science degree is required, with at least 7-10 years of experience in validation activities and/or projects management in a Regulated manufacturing environment. Experience with regulatory agency guidelines for medical device manufacturers. Proven record managing multiple complex, large-scale projects. Ability to prioritize projects. Advanced skills in Microsoft Project. Excellent verbal and written communication skills in English. Working experience managing resources. Possess and display sound judgment; initiative; flexibility and detail-orientation. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Project Management and Microsoft Project skills. Must live in Puerto Rico and speak Spanish. Fully bilingual (English and Spanish). One year contract 1416
