Plan, lead and coordinate all areas of Quality Assurance Services to exceed internal and external customer expectations in safety, quality, productivity, schedules, and employee relations. The ideal candidate will organize and control the processes, procedures, policies and activities for the assurance of the quality of the products according to the guidelines established by clients and in compliance with the ISO 9001: 2015 and ISO 13485.Responsibilities:Plan and implement programs that ensure quality according to the requirements and guidelines of customers and in compliance with quality standards.Oversee a team that includes software quality engineering, quality trainer and quality specialists.Assist with 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.Communicate effectively with all internal external customers to ensure that all production requirements, schedules, quality, and final deliveries of our products are satisfactory.Regularly ensure manufactured products are appropriately licensed, produced and marketed.Perform the proper evaluation, investigation and response to customer complaints.Make recommendations directly with manufacturing staff on the testing or trial usage of any new or alternate products and methods affecting product quality.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.Follow up and ensure that the personnel of the Department have the proper training to perform the job duties.Ensure adequate operational quality controls are developed to incorporate customer and regulatory requirements.Foster the continual use and implementation of the philosophies and tools that are taught through our Total Quality Program.Supports the risk based approach to the site QMS and operations.Helps drives the culture of continuous improvement.Perform other related duties as required.
