Projects & Validation QA Engineer

Cartago, Costa Rica

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ID de la oferta 59036 Área funcional Seguro de calidad Tiempo completo/tiempo parcial Tiempo completo Nivel de experiencia Profesionales

Projects & Validation QA Engineer

Heraeus Medevio

Location Cartago

Permanent

Full Time

Coordinate with New Product Introduction department the implementation of the projects related to process development and transfer of products validating the quality regulations and ensuring customer specifications and requirements to facilitate the transfers according to the timeline in robust and rapid way.

Major responsibilities:

⚪Ensure the transfers task are executed in a timely manner and coordinate the necessary requirements in the core team.
⚪Coordinate and lead the list of materials approved for export as the final phase of the transfer.
⚪Coordinate the containment of non-conforming product in order 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.
⚪Coordinate and lead the list of materials approved for export as the final phase of the transfer.
⚪Coordinate the containment of non-conforming product in order 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/Reports and new procedures for all processes, including Software, to assure the customer requirements.
⚪Coordinate with the core team to ensure that first articles are in full compliance with Company and Customer requirement before final pre-ship verification.
⚪Ensure the development and release of inspection plans and complete Pro-Novia approval assuring that specification is correct and available for inspection purpose.

Required Qualifications:

⚪Bachelor's degree in engineering or related.
⚪High level of knowledge on validations.
⚪Proficient with Microsoft Office.
⚪Fluent in spoken and written business English and Spanish.
⚪Knowledge of ISO 13485.
⚪Project management experience.

Experience:

⚪+5 Years of experience on Medical Industry.
⚪+5 Years of experience in similar positions.

Preferred Qualifications:

⚪Master's degree in project management.
⚪Knowledge of regulatory and MRP systems.

⚪Knowledge of ISO 17141.
⚪Certified on ISO 13485:2016 and/or 9001:2015 standards.

ReqID: 59036

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