Validation Specialist

Role: Project Validation Specialist III Location: Anasco, PR - 610 Duration: 12 Months Job Description: M-F Business Hours Summary Description: The position is to support the European Union Medical Device Regulation (EU MDR) program at Integra A asco, PR. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at Integra A asco, included in the EU MDR program. 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, technical