You enjoy quality and regulations. Especially when the issues relate to Medtech. The challenge of transforming complex regulations into something easy to understand is something that makes your heart beat a little faster. You want to be part of a group of helpful, competent and humble employees? Where we value and prioritize knowledge sharing, cooperation and care for each other. Have we just described you? Great!
Then you could be our next consultant colleague in QA/RA Medtech and IVD!
"Our group offers a warm and welcoming atmosphere where help is always available. We have a huge knowledge base and a strong commitment. Colleagues are friendly, helpful, competent and humble, creating a safe and welcoming environment for everyone. We strive to help each other grow and develop as consultants while solving problems for our customers and developing Plantvision together." - Colleagues
This is your role
With us, you will have the opportunity to work with customers and support them throughout their product life cycle and throughout their organization. You will be part of a team with very strong team spirit and values around working together and spreading knowledge together. Being a consultant with us is responsible and challenging, but above all very fun! The role gives you a lot of room to influence your own development through the assignments you work on.
With us you get:
- guide our customers through the regulatory world.
- work on applications, inspections, CAPA, clinical evaluation and standards.
- lead and/or participate in development projects.
- take a natural Location in our team that likes to talk quality, regulatory affairs and project management. We are a team of proud nerds who love to share our knowledge!
How you will shine
We shine by sharing our knowledge and so will you. Through your social and communication skills, you build trust with the people you meet. You have the ability to make complex information easy to understand, while accuracy and quality permeate everything you do. You are an independent person with good self-leadership skills, while you really enjoy being part of a team that is passionate about the same issues as you are. You enjoy and want to be part of a group of helpful, competent and humble colleagues.
If you have the following qualities, we think you will enjoy working with us:
- You have at least 3 years of experience in QA/RA in Medtech or IVD.
- You have a college or university degree in Life Sciences (MSc, BMA or PhD in relevant field).
- You are comfortable with both Swedish and English at a high level.
- You have experience in one of the following: You have worked with MDD/MDR, IVDD/IVDR, ISO 13485, ISO 15189, ISO 14971 or 21 CFR Part 820, FDA applications and MDSAP.
- You have experience in quality systems and have worked with e.g. non-conformity management, CAPA and inspections.You work on the development, update or assessment of technical documentation.
- You have worked with ICE 60601, IEC 62366 and other standards relevant to the performance evaluation of medical devices.
- You have experience in quality assurance of medical device software (stand-alone software, embedded medical device software or of computerized support systems in medical device companies (ICE 82304, ICE 62304, NIS 2, TR 80002, GAMP5).
Being part of Team PV
We are very proud to be a certified Great Place To Work company, which places us among the best employers in Sweden. The fact that we are also on the top list of Sweden's Best Workplaces is proof of the fantastic workplace culture we create together every day.
Our employees are the foundation of our success and we are very proud that the consultant drives his or her own development on a daily basis in parallel with how we as a company work with competence development and knowledge sharing. We are committed, not only to the work we do, but to the employee's everyday life as a whole. If we feel good and have fun together, we perform better together. That's why we put a lot of emphasis on work planning, parental leave compensation and various wellness activities, to name a few.
Application
If you think we are the right workplace for you and you are the right person for us, send in your application today! Selection is ongoing. Access takes place according to agreement.
If you have any questions about this position, please contact Ewa Kloskowska on 08-568 595 28 or ewa.kloskowska@plantvision.se.
or Pernilla Andrée on 08-401 00 53 or pernilla.andree@plantvision.se
For this recruitment, we have adopted a strategic approach and therefore refrain from calls from recruitment, staffing and advertising companies.
