Manager - Quality Assurance

Job Description

Responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by the clients and in compliance with the ISO 13485, reporting to Director Quality and Regulatory Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.

Implements and drives the culture of continuous improvement.

Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 9001: 2015 and ISO 13485:2016 and FDA.

Maintain daily communication with the Departments to follow the established processes and together take actions for the improvement or problems solution detected in the product or in the processes.

Responsible to follow up and ensure that the personnel of the Department under her responsibility have the proper training to performance the job duties.

Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.

Implements the risk based approach to the site QMS and operations.

Regulatory ensure manufactured products are appropriately licensed, produced and marketed.