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BD (Becton, Dickinson and Company) Manager Relabelling/Rework activities EDC Temse and Olen in Temse, Belgium

Job Description Summary

Manager Relabelling/rework activities (MIDC) EDC Temse and Olen

Are you Quality driven? Are you passionate about the medical industry and the applicable regulations? Then, this is the job you are looking for! We are looking for someone to join our EDC Quality Team.

As a manager for relabelling and rework activities in the distribution centers, you are responsible for managing EMEA (post manufacturing) product relabelling requests and ensure that compliant processes and controls associated with the different types of relabelling/rework activities are followed according to European Regulations and ISO standards, Corporate directives, and company strategies.

You liaise with the different (internal) stakeholders as appropriate such as Regulatory Affairs teams, Supply Chain, Business units and Manufacturers in order to meet their expectations, as well as to understand and comply with applicable regulations related to these processes.

You manage the internal relabelling teams in EDC Temse and Olen and the external partners by establishing best practices 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.

In this role, you report to the Senior manager Quality Logistics Network and the internal operational and admin teams from Temse and Olen are your direct reports.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why join us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

Your Responsibilities:

  • Organize and coordinate new/changed relabelling/rework activities, through collaboration with all parties involved like Supply Chain, QA/RA, Plants, Finance, EDC departments and external suppliers. Ensure the correct workload planning and prioritization accordingly.

  • Manage all incoming relabelling/rework requests, from solution proposal until approval for execution.

  • Communicate internally with all different departments in EDC (planning, inbound, outbound, transportation …) that are involved in the labeling process

  • Authorized and Responsible for the release or coordination of the release for changed products.

  • Responsible to organize and lead the EMEA labeling governance board as a decision making platform for new or changed relabelling projects.

  • Creating and updating the necessary Quality processes in compliance with ISO 13485 and investigate opportunities to improve the day-to-day processes in the relabelling team and at the suppliers.

  • Support in the qualification and performance evaluation of external relabelling partners 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 labelling/rework activities internally and at the external suppliers.

  • Follow up on performance based on quality metrics as agreed upon.

  • Manage complaints, CAPA’s and deviations related to relabelling/rework activities including the outsourced services in a timely and professional manner to assure consistency and accuracy of specifications and procedures necessary to maintain an effective Quality System.

  • Contribute to new business initiatives and projects, new regulations related to product labelling and review and communicate the impact on the EDC’s. Work with RA, BU’s and supply chain to come up with compliant and cost effective solution.

Your Profile:

  • You have experience in ISO 13485, GDP and GMP and European Regulations such as MDR, IVDR.

  • You are able to work within a Quality Management System especially ISO 13485.

  • You have experience in internal audits according to ISO 13485.

  • You are able to influence others and move toward a common vision or goal.

  • You are a true team player.

  • You are a real people manager.

  • 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.

  • You have a few years’ experience in managing a team ideally in an international environment.

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 !

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit: https://bd.com/careers

Primary Work Location

BEL Temse - Laagstraat

Additional Locations

BEL Olen

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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