**Ubicación**:
Cartago, Costa Rica, CR
**Familia de puestos**: Control de Calidad
**País**: Costa Rica
Job function summary
The Validation Engineer will be responsible for the execution of process and software validation activities under the organizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure compliance within external and internal requirements and ensure compliance to the quality management system.
Major areas of accountability
Issuing, completing, or approving validation documentation (protocols, deviations, reports, etc.)
Performing Installation, Operational, and Performance Qualification of equipment, instruments, and machines.
Performing validation of test methods for continues data and attributes.
Performing assessment about software changes and perform validation of software as appropriate
Creation of software validation plans and validation strategic plans as required
Issuing, updating, and approving Process Risk assessments
Investigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
Troubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders).
Handling of Process validation, Software validation and Risk assessments related Change Request tasks.
Collecting, organizing, and documenting test data.
Statistical analysis of data for process and test methods validation.
Ensuring accurate records of all validation activities.
Performing activities in a timely manner.
Performing with focus in the Corporate and department KPIs
Participation in internal and external audits as required.
Maintaining validation documentation throughout the validation life cycle.
Comply with internal and external instructions and work discipline in connection with work.
Participation on cross-functional teams related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or validation activity is needed.
Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job
Essential qualifications
Bach. degree in an Engineering field, such industrial, electrical, mechanical, etc.
Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
Experience in regulated industries (e.g., medical device industry).
Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
Experience with statistical software such as JMP, Minitab, etc.
Min. 3 years of experience in quality or production roles.
Fluent in both spoken and written English
Preferred qualifications
Numerical skills and understanding of data analysis/statistical methods.
Experience performing in validation roles
Mobile; capacity to travel abroad to received training and support transfer activities
Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 14 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nível mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.
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