Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Witten, Cologne and Jena. Abbott Automation Solutions in Hamburg (formerly GLP Systems) is now Abbott.

Abbott Rapid Diagnostics Division is looking for a

Product Verification and Validation Specialist ​(m/f/d) In-Vitro Diagnostics

based in Jena

Main Responsibilities:

• Co-ordination  and support of the product design verification and validation activities
• Working with cross-functional teams and/or external partners to conduct verification and validation studies, including Usability and Human factors engineering and Software validation
• Assisting in the definition of product and system requirements
• Development, co-ordination and execution of verification and validation studies
• Identification and sourcing or required materials as required and providing of cost estimates for verification/validation activities
• Preparation of plans and protocols
• Data analysis and reporting of results to multidisciplinary teams
• Appropriate resolution of discordant results
• Providing updates to the project team, escalating issues and providing recommendations for their resolution.

Your Profile:

• B.Sc/M.Sc. or Ph.D in relevant life sciences plus 3 to 5 years of professional experience preferably in a quality role within the medical device /IVD industry
• Expert knowledge of ISO 13485:2016 and 21 CFR 820 through training or actively working in SOP development
• Practical experience with implementing ISO:13485/IVDR/ FDA 21 CFR 820 requirements for product verification/validation, design control, usability engineering, product lifecycle processes, including the requirements related to the incorporation of software
• Willingness to travel

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.
 

Discover why candidates choose a career with Abbott in Germany.

AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce.

We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.