Job Description Summary

Job Description

Are you Quality driven? Are you passionate about the medical industry? Then, this is the job you are looking for! At BD 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 Document control, Cold Chain management, support in EU MDR activities & activities in Pharma process 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 in 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.

Your Responsibilities

• Maintain and improve the Quality Management System through internal auditing,document revision, 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 in 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.
• Responsible for temperature control /cold chain management (storage and shipping)
• Support in the EU MDR / Chloraprep management
• Ensures that the product quality issues and non-conform products are handled properly. 

Your Profile

• 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 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:

• A varied function with international contacts, within a company with an important social contribution in a value-driven organization.
• An informal working atmosphere, dynamic corporate culture, and an environment that lets you grow and develop.
• Unlimited possibilities for further development of your career, nationally and internationally.
• An attractive remuneration package.
• Training and education at BD University.
• An unlimited contract.

Are you interested in the position of Quality Engineer? Please apply below!

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