The regulatory challenges that will define the strategies of future in vitro diagnostics companies. It's what you know, what you're passionate about. You know how best to respond to the challenges our customers face. You love being at the forefront of your field and are happy to share your knowledge. Is that you we're describing? Great! Then the role of QA/RA specialist within IVD is for you.
This will be your role
As a consultant, you'll be challenged - and you'll find it really fun! You'll be managing QA/RA projects, taking on everything from applications and audits to CAPA and various development projects. You'll be part of a team of consultants who love talking about, and developing, quality and regulatory issues. The team spirit is strong and together we tackle all kinds of challenges.
- You will be able to influence your own development through the missions you are on and through the colleagues you have in your team.
- You will grow by taking on new, challenging assignments. Much will be new and you'll be working in areas you haven't done before.
- You will work independently but at the same time you will value belonging to the team and enjoy interacting and sharing knowledge across team members.
How you will shine
You excel in being flexible, proactive and driven. You are a person who puts the customer first with your positive approach and social skills. Of course, you show a great accuracy in your work, quality is the key word! Most of the work will take place on-site and you must be able to manage the balance between being part of, and actively contributing to, your team while being on-site.
Now that we see a great need for IVD expertise and we are growing in this area, we are looking for people with diverse backgrounds. However, common to all backgrounds is a minimum of five years' work experience. Of these, at least 1 year should be experience in a development company, government agency, notified body or equivalent where you have worked on Quality Assurance, Regulatory Affairs or product development issues. We are also looking for those who have worked in analytical performance, clinical performance, clinical evaluations and validation of analytical and laboratory methods.
- You have a university degree as BMA, MSc, PhD in a relevant field or equivalent.
- You are fluent in Swedish and English, both spoken and written.
- You can assimilate and write complex technical documentation and are able to draw your own conclusions.
- You have an educational approach where your ability to adapt calmly creates trust with those you meet.
In addition, we consider it very positive if you have experience in:
- Any or all standards such as ISO 13485, ISO 14971, ISO 3951-2, ISO 15189, ISO 9001, ISO 14001, IEC 62366, IEC 62304
- Having worked with product submissions, 510(k) and CE marking or experience with IVDD/IVDR, MDD/MDR, MDSAP, 21 CFR Part 820.
This is what you get with us
We are very proud to be a certified Great Place To Work company, which means we can count ourselves among the best employers in the country. The fact that we are also included in the top list of Sweden's Best Workplaces can only be seen as proof that together we have succeeded, and continue to succeed, in creating a fantastic culture.
Because we actually think we're different from traditional consultancies. Partly for the solutions we develop and partly for the way we develop them. And the key to both is the people who work here. Over the years, we've become a workplace that attracts the sharpest minds and the finest hearts. There's a saying that a culture is in the walls. With us, it's a warmth. In a way, we have soft walls.
Our customers meet us either as consultants in their own organisation, as advisors or when we manage the entire project delivery. No matter how, where or when they meet us, they get a person who cares about both their results and their new colleagues.
As our colleague you will, among other things:
- a secure job with a fixed monthly salary
- a strong culture of personal and professional development
- flexible working environment and great freedom under responsibility
- benefits, health allowances and health examinations
- occupational pension and 30 days' holiday
- compensation for parental leave
Application
If you think we are the right place for you and you are the right person for us, send us your application today! Selection will take place on a rolling basis. Start date is by agreement.
If you have questions about this position in Stockholm, please contact Judith Kairies on 08 568 595 00 or Judith.kairies@plantvision.se or Skåne Pascal Skogslund on 08 4010045 or pascal.skoglund@plantvision.se.
For this recruitment, we have adopted a strategic approach and therefore refrain from calls from recruitment, staffing and advertising companies.
