[D733] Quality Engineer II

[D733] Quality Engineer II

31 may

31 may



Job Description


Participates in the validation of new and existing equipment and processes,

application development and maintenance of quality standards of both in-process materials and finished products, ensures the application of approved test methods and develops instructions for use and calibration of equipment. testing, management, control and monitoring of the system of corrective actions and handling of non-conforming material for process improvement, application and monitoring of environmental control requirements, performs adequate training in them to all personnel involved. Participation in the activities of control of changes and in the evaluation of suppliers. Management,

monitoring and evaluation of customer complaints.


- Review and approve validation protocols for new and existing equipment through the use of approved procedures to ensure their quality

- Continue with the best practices and safety guidelines in the area, in order to

achieve KC's objectives

- Participate in the planned inspections and investigations of accident incidents for the EHS system

- Assisting the Manager of Quality Assurance in the planning, organization of the activities and work carried out in the quality department, such as the systems put into practice and maintaining the standards according to the FDA and the GMP. for the quality and conformation of the product

- Contribute by ensuring the maintenance of the required certifications, ensuring the availability of the product in the global market. This includes ISO 13485 and EN46002

- Review, verify, develop and validate the test methods for products and / or

processes by using applicable procedures to ensure that they meet the

established requirements

- Handle, execute and control the calibration and test equipment based on the

requirements to ensure that the tests are performed with reliable measurements based on the standards.

- Contribute to the investigation of the client's claims through the use of the

claims system established for the generation of the RCA and AP, as well as

contributing to maintain the responses to customers in a timely manner

- Ensure compliance with the requirements of quality standards and

regulations (ISO-13485, FDA / GMP, and others applicable), in accordance with established policies and procedures


SCHOOLING: Professional

ENGLISH: Advanced level.

EXPERIENCE: 4 to 6 years In the area of quality and experience in regulations for medical devices.

El anuncio original lo puedes encontrar en Kit Empleo:

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:
Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: [d733] quality engineer ii
Publica un nuevo anuncio gratuito
Necesitas publicar un anuncio? Con más de 1 millón de usuarios únicos al mes en corto encontrarás el candidato ideal para tu empresa, ¿qué estás esperando!
Publica ahora

Suscribete a esta alerta