Quality Systems Superintendent

**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. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)