ACERCA DE LA VACANTE
Funciones del Puesto
Provide Quality Engineering support to the development and production of Class I, II and III (as applicable) Medical Devices.
Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, maintain and manage quality compliance and supplier quality management.
Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology.
Participate in or lead Corrective/Preventive Action initiatives.
Support internal/ external and suppliers audit, vendor qualification and training programs.
Participate in Quality/ Business initiatives including business process improvement activities, documented Quality System re-architecture and other cross-functional projects.
Requisitos del Puesto
- Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).
- Bilingual English/Spanish - Advanced English level (written and spoken).
- Knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)
- Knowledge of process validation.
- Knowledge in root cause analysis tools.
- Knowledge of Minitab statistical software.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.
- Proficiency in the use of MS Project is a plus.
- Knowledge in software validation is a plus.
- Certified Quality Engineer or Green Belt is a plus.
- Certified Auditor is a plus.
Experiência Deseada
- At least 2 years work experience in manufacturing environment.
- Project Management experience.
- Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e.
food, aerospace, etc.)
is a plus.
Habilidades Deseadas
- Good interpersonal skills and the ability to communicate orally and in writing.
- Self-motivated.
- Organized and able to manage multiple tasks and priorities.
- Must be able to read and understand specifications.
Proficient in the interpretation of technical drawings.
- Must be able to work and effectively communicate with others.
- Highest ethical standards and professional integrity.
OTROS DETALLES
Area del Puesto
Control de Calidad
Ubicación del Puesto
Barreal de Heredia, Heredia, Costa Rica
Nível Académico
Bachillerato Universitario
Nível de Cómputo
Office Profesional
**Idiomas**:
Inglés: 70%