.**Careers that Change Lives**A Day in the LifeResponsibilities may include the following and other duties may be assigned.- Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.- Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.- May counsel stakeholders about these requirements as necessary.- Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.- Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.- Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.**Must Have: Minimum Requirements**- Bachelors degree required- Minimum of 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience**Nice to Have**Objetive: Manage CAPA, Complaints, Audits (Internal and External) and Risk Managem ent systems, responsible of the correct analysis and prese ntation of data and trends required for decisión making to ensure product quality.- Bachelor's degree in Industrial Engineering or equivalent.- Minimum 7 year of experience in the Medical Industry or similar roll.- Experience minimum of 3 years in handling corrective actions, complaints, audits, risk documents.- Advanced English- Personnel Management- Knowledge of techniques and use of Minitab- Management of BPCS, QDMS, Flow Tracking and Agile System- Experience in Validations process (Desirable).- Certificate in Lead Auditor ISO 13485: 2016 (Desirable)- Knowledge of 21 CFR Part 820 / ISO 13485 regulations.**Essential Funtion's**:- Responsible of CAPA system.- Responsible of Complaint system.- Responsible of Internal and External Audit systems- Responsible of Risk Management- Provide general support and follow up on plans to ensure adherence to 21 CFR, Part 820, ISO 13485 and other applicable regulations.- Scheduling, reporting, documenting and distribution of meeting minutes related to CAB Meetings.- Analize and maintain monthly reports, trends and documentation status of CAPA, Audit and Risk Management systems.- Analize, Identify and Communicate quality and compliance issues to plant managament, operations, manfuacturing personnel and suppor teams to help determine CAPA compliance.- Provide support in CAPA Investigations- Lead audits (Internal and External).- Provide support during FDA inspections.**About Medtronic**Together, we can change healthcare worldwide