.**Descripción de puesto**Facilitate product and process NCRs and Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.- Project manage all aspects of NCR/CAPA activity which includes gaining the commitment of cross functional resources, scheduling NCR/CAPA team meetings, and ensuring NCR/CAPA deliverables per project timelines.- Work effectively with all levels of management to ensure NCR/CAPA action plans can be supported and that costs/resources needed to implement the plan are available.- Provides training for NCR/CAPA team members as needed- Direct participation for HRAs (Health Risk Assessment) and Bounding list as part of NCR/CAPA process.- Risk evaluation analysis of process and product.- Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.G. Pride problem solving).- Responsible for assigned NCRs/CAPAs and will provide project direction, coaching, and mentoring or guidance to Investigation Team(s) and Actions Owner(s).- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA and NC issues.- Use technical/compliance information to guide and influence CAPA, NC and Compliance strategies.- Ensure compliance to requirements and the consistency and quality of CAPA and NC execution.- Leads elements of the rollout of any new NC/CAPA solutions (tools, techniques, and/or process enhancements).- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.- Presents NCE/CAPA metrics and analysis to CAPA review boards (CRB) as needed- Drive timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA and NC owners.- Builds productive working relationships and advocates for a collaborative work environment**Diversidad e Inclusión****El individuo**Bachelor's degree in an engineering related field required,At least +7 years of experience in Medical Device or regulated industryFull knowledge of other related disciplines (GPM, RA, QA, Quality Ops and R&D).Working knowledge of ISO 13485, 21 CFR Part 820.100.Must understand and know how to navigate a CAPA through the Quality System.Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.Ability to partner with the business and effectively interact with and influence employees, and managers on all levels.Able to understand and analyze complex problems, including software and hardware design issues