Senior Quality Assurance and Regulatory Consultants for Medical Device Development
Do you want to be part of the fast-growing Engineering part in Capgemini? Capgemini Engineering Denmark is still in a startup mode. You’ll therefore have a great opportunity to help us shape our future with regards to direction and setup. This year we have full focus on Life Science and Medical Device development and see great opportunities ahead! For our clients we are looking for an experienced consultant in Quality Assurance and Regulatory, to help us succeed on our larger project engagements. Join us and get the future you want!
As a consultant at Capgemini Engineering, you will be leading quality management in development projects related to medical devices or pharma related IT. You will be an important and close partner to the Project Manager in charge of the projects and will help ensuring the best way of achieving both quality and other project objectives and set a clear direction for the quality assurance.
In many of our client assignments, our consultants work in teams provided to the client by Capgemini Engineering – but in close collaboration with employees of the client. You may be working in accordance with Capgemini Engineering’s processes for design control and project management as well as with applicable standards, legislations, and client-specific processes to ensure quality assured activities and documentation throughout the design and development process.
Responsibilities (depending on clients and projects)
- Being the Quality Assurance Partner to running projects
- Be the focal point for GA activities and strategies
- Bring knowledge, insight, and focus on QA and RA to the project participants
- Working with our internal Nearshore and Offshore teams to coordinate efforts on QA and RA
- Being part of the development process from early phases until launch
Qualifications
- A degree in engineering, Master of Science, pharmacy degree or similar
- Long experience within development, design control and regulatory submission of medical devices, SaMD and Pharma related products
- Knowledge and experience working in accordance with: MDR, 21 CFR 800-series, ISO 13485, ISO 14971, IEC 62366 and/or IEC 62304
- Fluent in English.
About us
At Capgemini Engineering, you are part of something bigger. Our close cooperation with other entities within the Capgemini Group will give you the opportunity to explore endless possibilities. We have offices all over the world, and the Capgemini family consists of more than 340 000 colleagues globally. In Denmark we have offices in Copenhagen and Århus.
We support your personal development and offer an education library with more than 250 000 (!) courses and educations and certifications. We encourage internal promotions and your continuous growth within our company.
Our work philosophy “Live your best work life”
You probably wouldn’t be reading these lines if you didn’t already possess an inherent passion for managing complex processes and solving intricate business challenges – and perhaps even make the world a slightly better place in the process. Perhaps you are driven by a desire to innovate fueled by a potent mix of curiosity, creativity and that wonderful sense of accomplishment that comes afterwards. We all love that…
But at Capgemini Denmark we know, that a good work life consists of more than professional challenges, professional development and hygiene factors such as salary and benefits. We also need to have a rich, present and meaningful life outside the workplace. That’s why we have a flexible work philosophy that helps you shape and develop your career, while at the same time making room for what’s important outside work – the things that help give your work meaning and also enable you to live your best work life.
Application and contact
If you have any questions regarding the job opening or your application, please contact Talent Acquisition Team lead, Anette Nilsen, at + 46 730250517 or Director of Delivery Capgemini Engineering, Denmark, Mads Madsen at +45 52 18 90 03
Work with great people
About the company
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.
Get the Future You Want | www.capgemini.com
1997IT consultancy company Consignit AB is founded in Gothenburg, Sweden.
2003Altran Group acquires Consignit AB.
2015Altran Group launches new company strategy - Ignition. The strategy united the countries within Altran Group and was the starting point of a successful period of growth.
2020Capgemini Group acquires Altran Group and its 50,000 employees. Post acquisition, Capgemini will have combined employee strength of 250,000 globally.
2021On April 8th Altran Group turn in to Capgemini Engineering, this name change is an important step of the ongoing integration journey.
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