Prin IT Quality Systems Spec

hace 4 semanas

San Vicente Ferrer, Colombia Medtronic A tiempo completo

**Careers that Change Lives**

**We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.**

**Bring your talents to an industry leader in medical technology and healthcare solutions - we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.**

**A Day in the Life**

**Responsibilities may include the following and other duties may be assigned.**
- **Provides oversight for the development and maintenance of quality programs, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.**:

- **Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.**:

- **Works directly with process owners to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. This includes managing planning, development, reviews, approvals / releases of quality management system process, work instructions, and form changes to a defined schedule.**:

- **Provides oversight of regulation changes and assess impact to IT governed processes that ensure compliance with established standards and regulations.**:

- **Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.**:

- **Responsible for CAPAs that are part of the IT portfolio and / or CAPAs that are within a business CAPA board oversight that includes IT systemic issues.**:

- **Manages each phase of the systemic issue including issue triage, investigation, action, and effectiveness adhering to the policies, procedures and Key Performance Indicators set within our quality manual.**:

- **Collaborates and influences effectively with global IT leaders and their resources on methods to prevent the issues and staff the work in each of the CAPA phases. Includes project management skills and methods that are used within the IT organization for effective resourcing of work needed to support CAPAs at projects.**:

- **Create and execute change management plans for collaboration of change with the global IT community impacted by the changes to the QMS.**:

- **Support defensibility of processes and changes in external and internal audits. This can entail leading audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.**:

- **Contributes to simplified process approaches and ways to execute to the process changes for the roles in IT that deliver on making it easier to get work done.**:

- **Organizational Impact: Contributes to defining the direction for new processes, standards, or operational plans based on business strategy with a significant impact on work group results.**:

- **Autonomy: Recognized expert, managing large projects or processes.**:

- **Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.**:

- **Coaches, reviews, and delegates work to lower-level specialists.**:

- **May manage large projects or processes that span outside of immediate job area.**:

- **Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.**

**Must Have: Minimum Requirements**
- **Bachelor’s degree life science.**:

- **7 years of experience with systems validations, maintenances, strategies, and accurate review of specific documentation as required by the IT Product and non-product software validation experience**:

- **CAPA root cause analysis methods skills.**:

- **Audit experience in life science areas.**:

- **Fluent in English level.**:

- **Knowledge in MS Office.**:

- **Collaboration with different regions.**:

- **Use of standard quality management systems tools in the industry (Oracle, Map agile, etc )**:

- **Solid understanding of the quality regulations and auditing techniques required for the medical device industry.**:

- **Ability to create and deliver presentations up to the Executive Committee level.**:

- **Strong influencing and negotiation skills**:

- **High energy and motivation with an ability to quickly adapt to change**:

- **Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance process

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