Eng Jr, Validations
hace 2 días
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
**Lo que realizarás**:
1. Promote continued compliance with ISO13485 and FDA Part 820 for the manufacture of medical devices.
2. Provide support in execution of qualification and validation process activities.
3. Support in the execution of Qualification of critical equipment and systems used in manufacturing processes.
4. To give support in the activities that give fulfillment to the Validation Master Plan in force.
5. Support and/or elaborate validation protocols and reports.
6. Collect information attached to the validation protocols.
7. Support validation activities as required, such as processing document changes, updating and auditing logs, writing Gap analysis, among others.
8. Provide support for computer system validation compliance and data integrity enforcement.
9. Provide support in the execution of test method validations.
10. Provides support and/or performs maintenance of validated status.
11. Support in the qualification and operation of the controlled areas within the applicable environmental specifications.
12. Support in regulatory inspections.
13. Provide support in the investigation of internal and external audit observations related to the area of validation.
14. Comply with the Health and Safety, ISO 14001 (Environmental Management) and NOM-041 systems, as well as those applicable.
16. Use assigned personal protective equipment (PPE) in accordance with NOM-017.
**Reasonable Accommodation**
**Recruitment Fraud Notice**
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