BD (Becton, Dickinson and Company) Quality Engineer (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.
As Quality Engineer you will provide representation on product development teams as required. You will initiate new/revised documentation and track through approval cycles and implementation. Your duties will include the performing of gap analyses for legacy products to ensure current international standards and regulations are met. You will develop physical and functional test methods to ensure specifications are met. Furthermore, you will be in charge of:
Participate in cross-functional teams to develop risk assessment
Write and/or review design verification and validation protocols and reports
Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications
Conduct and /or coordinate testing outlined in protocols and test methods
Perform process improvement, control and monitoring on manufacturing processes
Participate and provide input to training on department/division procedures, and policies
Participate in project planning, budgeting, scheduling and tracking
Develop and implement procedures to provide easy to follow instructions
Understand and follow company procedures on regulatory requirements
Provide a positive example and actively promote compliance with all standards
Maintain a professional working relationship with internal and external customer and support staff
Prepare and present project updates and technical discussions
You have a Bachelor’s degree in Engineering, Quality or a related technical field.
Preferably you have experience in the healthcare sector or similar. You bring general knowledge of FDA GMP/GLP, Medical Device Directive, and ISO and have the ability to make and present engineering decisions. Furthermore, you have:
Product development experience
Design validation experience
Ability to analyze and optimize manufacturing and quality systems
Software application skills
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
Ability to work on cross-functional teams
Fluency in German and English
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.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community at http://bd.tal3nt.community/ / at http://bd.tal3nt.community/
Primary Work Location
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.