Do you want to be part of ensuring quality in Life Science together with the best minds in the industry? Then this is where you should be.
With us, exciting assignments await you - assignments that require curiosity, sharp minds and a desire to find solutions where others see challenges. The variety of our projects means that you can constantly develop and put your skills to the test in new contexts. At the same time, you get to contribute to something bigger.
Through our work, we help shape the solutions of tomorrow - making a difference for people, society and the future. We do all this together, in teams filled with some of the industry's sharpest and most experienced colleagues. Here we are inspired by each other, share knowledge generously and drive development forward - with quality, curiosity and sharpness as common ground.
This will be 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 a very strong team spirit and values around working together and sharing 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, among others.
- 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 excel at 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 independent with good self-leadership skills, while really enjoying being part of a team that is passionate about the same issues as you are. You thrive in 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 with quality systems and worked with e.g. deviation management, CAPA and inspections.You work with the development, updating 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 a consulting company that is passionate about being part of Life Science in Sweden. From the small MedTech start-up to the global pharmaceutical giant and everything in between. It means an opportunity to follow the whole chain - from manufacturing to use in healthcare - and work with everything from regulations and audits to project management, standards and evaluations. Helping our customers achieve their goals is what drives us. So, if you want to be part of something bigger, something that makes a real difference and can actually, ultimately, save lives and keep patients safe - then you've come to the right place. We have some of the brightest minds in the industry working for us, and as part of Plantvision Compliance, you'll be an incredibly important cog in our constant quest to make a difference. For real.
Awards and accolades aren't everything, but we're proud to be a certified Great Place To Work (for the ninth year in a row, in fact), which means we're one of the best employers in Sweden. With us, you get something different. What sets us apart from traditional consultancies is our unique culture, which stands out and permeates everything we do. Inclusive, supportive and stimulating. We see you.
Together we can move mountains. Today, tomorrow and beyond.
Application
You are welcome to send in your application as soon as possible. Selection and interviews are ongoing, the position may be filled before the deadline, which is May 31.
We look forward to receiving your application.
If you have any questions About this position , you are welcome to contact Pascal Skoglund on 072 566 99 87 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.
