Sr. Quality Engineer - Nogales

Sr.

Quality Engineer - Nogales

Job Description

You’re not the person who will settle for just any role.

Neither are we.

Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference.

Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands.

In this role, you’ll help us deliver better care for billions of people around the world.

It starts with YOU.

In this role, you will:


* 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.


* Follow the requirements of the environmental policy


* 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.


* Coordinate, review and apply the methods of material and process inspection through the use of approved procedures to ensure their quality in all stages of manufacturing.


* 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 in the process of corrective actions from its beginning to its completion based on the procedures established to ensure compliance.


* 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.


* Develop and maintain the controlled environment in all the required process areas through the control processes of bacteria, pests, positive pressure, hygiene, etc.


* Comply with all security requirements that have been established as well as active participation in all development and monitoring activities of the EHS system.


* Analyze the necessary statistics to be able to monitor the non-conforming product, the DPM of receipt, process and packaging with trends that allow us to determine its capacity.


* Provide the necessary training to all the personnel involved, maintain the training needs system of the Qu...