Job Description Summary
Are you Quality driven? Are you passionate about the medical industry? Then, this is the job you are looking for! We are looking for someone to join our EDC Quality Team.
As a Quality Engineer you are 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.
You will ensure that the product quality issues and non-conform products are handled properly. You liaise with the European and non-European production plants as appropriate.
You will have an active role concerning training and guidance for improvement initiatives in order to maintain and improve the effectiveness of our quality system.
While reporting 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 and ISO 13485, are effectively established, implemented, and maintained.
Organize and / or participate to the required (periodical) audit plans in order to verify the effectiveness of our operational processes.
Establish, implement and sustain the Quality Management policy and principles.
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.
You have a Master or a Bachelor degree
You have experience in ISO and European Regulations, preferably medical device industry, with exposure to document and data control processes
You are able to work within a Quality Management System especially ISO9001 an ISO 13485
You are knowledgeable of GDP ( Good Distribution Practices) / warehousing is a plus
You are a Certified auditor, ISO 13485 with experience in managing internal audit program or strong interest in obtaining this certificate is a plus
You have the ability to influence others and move toward a common vision or goal
You are able to work effectively at all levels in an organization
You are fluent in Dutch and English
What we can offer you
It goes without saying that BD offers excellent terms of employment;
Unlimited possibilities for further development of your career, nationally and internationally ;
Training and education at BD University;
You are part of a company that makes a concrete contribution to global health care, saving and improving the lives of people around the world;
The opportunity to participate in an international volunteer program;
BD has an active staff association that organizes everything for employees and their families every year.
Interested? Click on the APPLY button !