Company Description
AFRY is an international engineering, design and consulting company. We accelerate the transition to a sustainable society.
We are 19,000 dedicated experts in the fields of infrastructure, industry, energy and digitalization working across the globe to create sustainable solutions for future generations.
Inclusion and diversity - We want to attract people with different backgrounds and perspectives to our organization. Diversity is positive in many ways for us at AFRY. We know that it drives both creativity and innovation.
Job description
Do you dream of working with and contributing to the development of life-saving products? Do you want to help our customers in Life Science and MedTech navigate the jungle of standards and legislation to be able to place safe products on the market?
In your role as a consultant with us, you will mainly work in assignments with our customers. As our assignments vary over time, you will have the opportunity to both use and develop your knowledge in quality assurance and / or regulatory work.
As a consultant with us, you can, among other things, work with the following at the customer:
Establish and follow up routines and quality-driving processes, e.g. deviations, changes.Be a quality representative in e.g. product development projects, risk management and development of specifications.
Plan, implement and follow up audits.
Create and compile product documentation for product applications.
Review quality documents and project documentation.
Communicate with, and prepare for inspection by authorities and Notified Bodies.
GAP analysis of compliance with regulations or standards
Handle complaints and lead complaint investigations
Who are we?
Our Compliance & Quality Management (CQM) section consists of about 30 employees in Mälardalen, Malmö and Gothenburg. The section is run by Britta-Stina together with group manager Lars and our team leader Jacob. Among our employees, who are everything from new graduates to seniors, there is a broad competence in quality, compliance and business development. We work with products throughout their life cycle or processes throughout the company's organization in different industries and organizations.
Qualifications
Either you are a civil/university engineer at the beginning of your career who finds medical technology, regulatory work and standards exciting or you are more senior and have previous experience with MDR, IVDR, ISO 13485, ISO 14971 and/or 21 CFR Part 820. Experience with ER/ES, Premarket Notification, Premarket Approval and Labeling is a plus.
You are looking for a job that is challenging, fun and requires drive while you will of course be supported by your colleagues. You are flexible, have a structured approach and are good at working independently. You are also a good communicator and have a good knowledge of Swedish and English, both spoken and written.
Further information
Our consulting group is characterized by collaboration, openness, professionalism and we are driven by creating added value for our customers. In addition to consulting services, our business area can also offer our customers packaged solutions and products.
We offer a workplace with a forward-looking spirit and security in the form of collective agreements and staff benefits for all our employees. Our staff club organizes social activities in and outside the office. From ski trips, singing in a choir to playing board games - there is something for everyone.
We are looking for you who want to be part of AFRY's success story. Are you passionate about technical development? Do you like to collaborate to find the best solution? Then we can offer you career opportunities in a modern workplace with challenging tasks and exciting projects worldwide.
Contact details for questions
For questions regarding the position, please contact Segment Manager Britta-Stina Karlsson brittastina.karlsson@afry.com
For questions regarding the recruitment process, please contact Recruitment Partner Fanny Sjödell, fanny.sjodell@afry.com
Apply via the application button as we cannot accept applications via email.
Please apply no later than 4/5!
At AFRY, we drive change in everything we do. We believe that change happens when bold ideas come together, when we collaborate, innovate and embrace creative solutions, that's how we create the future. We are constantly looking for qualified candidates to join our inclusive teams around the world. Join us and accelerate the green transition