Projects and Validation Quality Engineer II

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

•            Bachelor’s degree in Engineering or related

•            Master’s 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