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 Specialist Outsourced Logistics you are responsible for managing EMEA quality processes and controls associated with the Outsourced Logistics Service partners such as logistics service providers, rework handling, and overflow warehouses.
This includes CAPA management (Corrective and Preventive Actions), Audits, Document control, Cold chain management, and other activities related to European Regulations and ISO compliance, Corporate directives, and company strategies.
As the Quality Specialist Outsourced Logistics, you ensure that the product quality issues and non-conform products are handled properly.
You liaise with the different stakeholders as appropriate and you have an active role concerning training and guidance for improvement initiatives in order to maintain and improve the effectiveness of our quality system.
You report to the Senior manager Quality Logistics Network.
Your Responsibilities :
Ensure BD’s Quality Management System requirements in accordance with European Regulations, GDP / GMP for Pharmaceuticals, and ISO 13485, are effectively communicated, established, implemented, and maintained at the Logistics Service Providers (LSP’s).
Creating and updating the necessary Quality processes and investigate opportunities to improve the day-to-day processes between BD and the LSP’s.
Support in the qualification of new outsourced processes and ensure all required requirements are fulfilled such as Quality Agreements.
Organize and / or participate in the required (periodical) audit plans in order to verify the effectiveness of our operational outsourced processes.
Follow up on performance based on quality metrics as agreed upon with the Outsourced parties.
Manage CAPA’s and deviations related to outsourced services to assure consistency and accuracy of specifications and procedures necessary to maintain an effective Quality System.
Contribute to new business initiatives and projects and review and communicate the impact on Supplier Quality activities.
Responsible for the follow-up on in-quarantine shipments, if applicable, quality holds and recalls in order to ensure that not any of these products can leave the logistic services providers and to ensure that they are properly handled.
Guidance on Return management.
Review and monitoring of operational processes at LSP’s like relabeling and repacking, if applicable.
Your Profile :
You have experience in ISO 13485 and European Regulations such as MDR, IVDR.
You are able to work within a Quality Management System especially ISO 13485.
You are a certified auditor, ISO 13485 with experience in managing an internal audit program, or strong interest in obtaining this certificate!
You are able to influence others and move toward a common vision or goal.
You are a true team player.
You are able to work effectively at all levels in an organization.
You have experience managing a corrective and preventive action program.
You have knowledge of documentation requirements.
You have excellent verbal and written communication skills in English and Dutch.
What we can offer you :
A broad and challenging position with an attractive remuneration package.
An informal working atmosphere with a dynamic corporate culture and an environment that lets you grow and develop!
Being part of a company that makes a concrete contribution to global health care, saving and improving the lives of people around the world.
Unlimited possibilities for further development of your career, nationally and internationally.
Are you interested to work in the medical device industry? Please Apply !