Prin Quality Systems Spec

hace 5 meses


Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives
**We are seeking a driven and talented individual to join our Quality team.

This position requires the ability to support the Medtronic IT systems validations, maintenances, 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.

**A Day in the Life**
Responsibilities may include the following and other duties may be assigned
- Serves as the quality expert for assigned programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality. Ensures deliverables are aligned to process.
- Delivers strong written and verbal communication skills with ability to communicate effectively to a wide audience, including subordinates, peers, and superiors, and requires mínimal supervision.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Provides oversight for the development and maintenance of quality programs, systems, and processes that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Lead and influence Quality System procedures and process improvements including developing and updating and owning procedures.
- In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes.
- Trains and mentors other Quality department staff to perform quality duties.

**Must Have: Minimum Requirements**
- Bachelor’s degree in a Science related field or equivalent experience.
- 5 or 6 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.
- Knowledge in Healthcare software, ISO 82304.
- Fluent in English level.
- Experience with software validation methodologies.
- Knowledge with Non-product software including 21 CFR Part 11 and/or healthcare validation delivery experience.
- Proficiency in Microsoft Tools including Word, Excel, Teams, SharePoint.
- Familiarity with validation of various system hosting configurations (cloud, on-prem).
- Experience with data migration.
- Must be proficient in multitasking and time management.
- Team player.
- Excellent communication skills.
- Knowledge and experience in IT Quality.
- Cloud Solutions, AWS knowledge.
- Excellent critical thinking and detail orientation.

**Nice to Have**
- 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.
- Has a history of completing successful projects and driving positive compliance outcomes is a plus.
- Solid working knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, QSR/ ISO 13485 regulations and standards is a plus.
- History of driving results with a sense of urgency, good communications skills, and ability to manage details is a plus.
- Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment.
- Experience shifting CSV to CSA implementation is a plus.

**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 mea


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