Projects and Validation Quality Engineer II
Job ID 57592 Funktionsbereich Qualitätsmanagement Vollzeit/Teilzeit Vollzeit Einstiegslevel Berufserfahrene Projects & Validations Quality Engineer II Full time Location: Free Zone la Lima Cartago
RESPONSIBILITIES
- Ensure the transfers task are executed in a timely manner and coordinate the necessary requirements in the core team.
- Perform Quality Due Diligence activities to confirm that transfer projects are complying.
- Execute Test Method Validations/ gage R&R and review and approval validation Protocols to follow the procedures and be compliance with quality regulations.
- Evaluate Validation Protocols/Reports for all processes, including Software, to assure the customer requirements.
- Ensure that first articles are in full compliance with Company and Customer requirement before final pre-ship verification.
- Check the development and release of inspection plans and complete Pro-Novia and CCID Tasks assuring that specification is correct and available for inspection purpose.
- Create and Review work instructions associated with inspection techniques and inspection equipment to ensure the validation process.
- Perform the containment of non-conforming product to make sure that it cannot be shipped out of the site.
- Keep an adequate organizational environment to promote the values and Culture of HMCR.
- Support current and future business needs through the development, engagement, motivation, and preservation of human capital.
- Approve validation protocols in continuous improvement projects to increase business capacity and efficiency
REQUIREMENTS
- Bachelors degree in Engineering or related
- Masters degree in project management/ desirable
- Strong of knowledge on validations
- Knowledge of regulatory and MRP systems./ Desirable
- Proficient with Microsoft Office
- Fluent in spoken and written business English and Spanish
- Knowledge of ISO 13485
- Knowledge of ISO 17141
- +3 Years of experience medical cluster
- +3 Years of experience in similar positions
- Project management experience
Candidates, interested in requisition Projects & Validation Quality Engineer II, are invited to apply online or contact jobs-medevio@heraeus.com for further questions - both will of course be treated confidentially.
ReqID: 57592Information :
- Company : Heraeus Holding GmbH
- Position : Projects and Validation Quality Engineer II
- Location : Cartago, Provincia de Cartago
- Country : CR
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Post Date : 2025-05-05 | Expired Date : 2025-06-04