IT Quality Systems Spec

hace 3 semanas

Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives
This position requires the ability to support the Medtronic IT systems validations, maintenance, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their severity and address gaps in a methodical way to reduce overall organization exposure.

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.

Join us for a career in IT that changes lives.

**A Day in the Life**
- Provides oversight for systems validations, maintenances, strategies, and accurate review of specific documentation as required by the IT quality processes that ensure compliance with established standards and regulations.
- Review validation deliverables and provide feedback to corrections to align to process.
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Collaborates with global IT quality peers and project teams on project scope, schedule and compliance guidance.
- Contributes to simplified validation approaches and coaching on how to leverage these approaches with their projects including resources such as Business Analysts, Developers, Test Leads, Testers, and Project Managers.
- Works independently with general supervision on larger, moderately complex projects / assignments.
- Supports the external audit IT team on timely retrieval of quality documentation related to the systems, reports, and spreadsheet validation efforts they manage.
- Make adjustments or recommends enhancements to improve process alignment.

**Must Have: Minimum Requirements**
- Bachelor’s degree in a Science related field or equivalent experience.
- 2 years of experience with systems validations, maintenances, strategies, and accurate review of specific documentation as required by the IT quality processes that ensure compliance with established standards and regulations **.**:

- Fluent in English level.
- Knowledge in Healthcare software, ISO 82304.
- Experience with software validation methodologies.
- Knowledge with product, non-product software, and/or healthcare validation delivery experience including 21 CFR Part 11.
- Proficiency in Microsoft Tools including Word, Excel, Teams, SharePoint.
- Must be proficient in multitasking and time management.
- Team player.
- Excellent communication skills.
- Solid understanding of the quality regulations and auditing techniques required for the medical device industry.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
- Strong influencing and negotiation skills.
- High energy and motivation with an ability to quickly adapt to change.

**Nice to Have**
- Previous Medtronic experience.
- Experience to work in a global, virtual organization.
- Familiarity with validation of various system hosting configurations (cloud, on-prem).
- Experience with data migration.

**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 Requirements

The 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 o

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