BD (Becton, Dickinson and Company) Quality Engineer in Temse, Belgium
Job Description Summary
The Quality Engineer is responsible for managing European processes and controls associated with the EDC Quality Management System, including CAPA (Corrective and Preventive Actions), Internal and External audits, Document control,Management responsibility and other activities related to European Regulations and ISO compliance, Corporate directives, and company strategies.
The Quality Engineer ensures that the product quality issues and non-conform products are handled properly. He/she liaises with the European and non-European production plants as appropriate. He/she needs to have an active role with regards to training and guidance for improvement initiatives in order to maintain and improve the effectiveness of our quality system.
In addition, the Quality Engineer may act as (back up) Responsible Person (RP) for Medicines in the EDC. The Quality Engineer reports to the EDC Quality manager.
Maintain and improve the Quality Management System through internal auditing,
document revision, quality training and process improvement initiatives
Ensure Quality Management System requirements in accordance with European Regulations, GDP/GMP for Pharmacueticals and ISO 13485, are effectively established, implemented, and maintained.
Updating the necessary Quality processes and investigate opportunities to improve the day-to-day processes and develop policies and procedures to maintain and improve the performance of the quality system ISO13485, in combination with GDP/GMP requirements.
Manage the EDC internal quality audit program to ensure compliance to ISO 13485 and GDP as required.
Organize and/or participate to the required (periodical) audit plans in order to verify the effectiveness of our operational processes.
Documentation and Training
Establish, implement and sustain the Quality Management policy and principles.
Organize training modules to educate associates in areas as ISO 13485 Requirements, Good Distribution Practices and Regulatory Requirements in order to promote Quality Awareness at all employee levels.
Works closely with other departments to ensure compliance and maintain the highest quality standards.
Manage site CAPA process to assure consistency and accuracy of specifications and procedures necessary to maintain an effective Quality System.
Responsible for the follow-up on in-quarantine shipments, quality holds and recalls in order to ensure that not any of these products can leave the distribution center and to ensure that they are properly handled.
Ensures that the product quality issues and non-conform products are handled properly. He/she liaises with the European and non-European production plants as appropriate. at http://www.bd.com/careers
Primary Work Location
BEL Temse - Laagstraat
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.