- 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 or Engineering related field or equivalent experience
- At least 2 years of relevant experience
- Experience with software validation methodologies and processes documentation
- Product, non-product software, and/or healthcare validation delivery experience
- Proficiency in Microsoft Tools including Word, Excel, Teams, SharePoint
- Must be proficient in multitasking and time management
- High energy and motivation with an ability to quickly adapt to change
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication
- Proficiency in English
- Familiarity with validation of various system hosting configurations
- Experience with data migration
- Solid understanding of the quality regulations and auditing techniques required for the medical device industry
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IT Quality Systems Specialist - Bogotá, Colombia - Medtronic
Descripción
Careers that Change LivesWe 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.
Medtronic is committed to fostering a diverse and inclusive culture. Check out the accomplishments of our Women in IT group
A Day in the LifeResponsibilities may include the following and other duties may be assigned.
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