Project Validation Specialist, Sr. - Añasco

Perform assessments and review of manufacturing and validation documentation associated to product families established by EU MDR and Design History File (DHF) remediation program. Provide data to support the gap assessments reports and identify remedial action items. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes, such as drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, etc. Analyze manufacturing process information/data, and develop technical justification to mitigate risk to acceptable level with adequate documentation.
Requisitos:
BS in Engineering or Science degree are required, along with at least 7 years of experience in projects management and/or validation activities in a Regulated manufacturing environment. Experience with regulatory agency guidelines for medical device manufacturers. Project Management Professional (PMP) Certification is preferred. 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. Knowledge and work experience with Project budgets and financial management is a plus. Must live in Puerto Rico and speak Spanish. Fully bilingual (English and Spanish). One year contract 1336