BD (Becton, Dickinson and Company) Quality Engineer Post-Market Surveillance (m/f) in Karlsruhe, Germany

Job Description Summary

BD (Becton, Dickinson and Company), a leading global medical technology company, has acquired C. R. Bard, Inc., creating a new health care industry leader with approximately $16 billion in annualized revenue.

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

Job Description

As Quality Engineer you will coordinate and organize the Post Market Surveillance (PMS) Program in accordance with applicable international regulatory requirements. In this role, you will work closely with cross- functional teams to implement and maintain an effective PMS system and perform gap analyses for legacy products to ensure current international standards and regulations are met. Furthermore, your duties will include:

  • Conducting of PMS reviews per established SOPs and tracks action items accordingly

  • Ensuring proper analysis of product quality and safety information

  • Initiating corrective and preventative actions as needed

About you

You have a Bachelor’s degree or a higher graduate degree in a science/engineering, a related field, or have equivalent experience. General knowledge of FDA GMP/GLP, Medical Device Directive, and ISO 13485, ISO 14971. You are process orientated with good attention to detail and have strong interpersonal skills. Furthermore, you have:

  • Ability to analyze and optimize quality systems

  • Ability to create and provide training

  • Software application skills

  • Problem-solving ability

  • Oral and written presentation skills

  • Ability to work on cross-functional teams

  • Fluency in German and English

We Offer

Collaboration in a highly motivated global environment. A familiar work climate in an innovative environment where your input counts. A safe workplace with long-term perspectives. We endeavor a long-term collaboration – hence corporate career planning throughout diverse phases of life conveys a high importance and value for us.

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Primary Work Location

DEU Karlsruhe

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.