Inclusion and Engagement

BD is one of the largest global medical technology companies in the world. ™ 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

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

The tasks and responsibilities as Management Representative consist of::

• Providing leadership for the plant quality organization and for the efficient operation of the quality system in order to meet customer needs and regulatory requirements
• Creating and updating of the quality manual
• Planning, developing, maintaining and improving the quality management system
• Ensure compliance with QM requirements, both to above site and Heidelberg specific requirements
• Assuring quality of product and processes
• Assuring compliance to ISO 13485, GMP and other relevant external standards as well as to BD internal corporate standards
• Assuring regulatory compliance (by adequately setting up the PRRC role, i.e. person responsible for regulatory compliance)
• Assuring compliance to the requirements for the legal manufacturer
• Maintaining and monitoring quality metrics and derive relevant actions to improve these
• Support and collaboration within the global matrix organization and other functions (Corporate quality, Business, Distribution and Logistics, etc.)
• Providing quality business partnership within the Heidelberg plant
• Preparing and performing management reviews
• Identifying and driving quality improvement initiatives
• Providing other kind of tasks and responsibilities at the direction of his manager
• The Management Representative has independent decision-making and approval authority over local quality processes and can initiate situation analyses (field action process) and global hold processes

Education and Experience:

• The incumbent´s minimum qualification and experience include:
• Completed degree in a natural science (e.g. microbiology, chemistry, biotechnology) or engineering topic (e.g. food processing or pharmaceutical engineering)
• Professional experience comprises a minimum of 4 years in the in vitro diagnostics or similar industry (e.g. food processing, medical devices, pharmaceuticals, chemistry)
• Good leadership skills including people management
• Good knowledge of ISO 13485, ISO 17025, GMP, IVDR and other quality system regulation requirements
• Ability to analyze data, prepare and present analyses and conclusions to targeted to different audiences (e.g. shop floor representatives, management functions)
• Good mastering of root cause analysis processes, tool and statistical methods to support them
• Basic Lean-Six-Sigma skills, Lean-Six-Sigma greenbelt preferred
• Very good language skills in German and English
• Very good knowledge and understanding of common software applications (e.g. MS Office, SAP, TrackWise, etc.)