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Projects & Validations II

Cartago, California

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Job ID 58342 Functional area Quality Assurance Full-time/part-time Full Time Experience level Graduate

Projects & Validations II

Projects and Validations Quality Engineer II 

JOB PURPOSE

Coordinate with New Product Introduction/Transfer/PMO department with 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.  

  • Approve Validation Protocols/Reports and new procedures for all processes, including Software, to assure the customer requirements. 

  • Coordinate with the coreteam 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.  

  • 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. 

  • Executing production sustainable practices to promote a culture of energy efficiency within the company.  

EDUCATION 

  • Bachelor’s degree in Engineering or related  

KNOWLEDGE AND SKILLS

  • High level of knowledge on validations 

  • Proficient with Microsoft Office 

  • Fluent in spoken and written business English and Spanish 

  • Knowledge of ISO 13485 

EXPERIENCE

  • +3 Years of experience on Medical Industry 

  • +3 Years of experience in similar positions 

  • Project management experience 


ReqID: 58342
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