QA/RA Manager, Helsingborg

Job description
Here is an exciting opportunity as a QA/RA Manager at Vigmed! You will get to add value and experience in a role that is both operational and strategical. Driving the QA and RA agenda, joining the management team in Sweden and also having an impact on the global project of achieving an MDR certification. Grab the chance to both learn and contribute!

Responsibilities
As a QA/RA Manager at Vigmed you will get to lead the QA/RA activities and also manage the QA Engineer. As mentioned, you will be part of the Vigmed management team and have a central part and bring expertise in the global project, where Vigmed together with Greiner Bio-One will achieve a MDR certification. You will have the opportunity to be an influencer in the project all the way. 

You will get to take ownership of the QMS system and ensure that it is in accordance with demands from MDD, ISO standards and requirements from Notified body. Later on, you will also be part to ensure that MDR and FDA requirements are fulfilled.

In development projects, you will have the opportunity to be the QA/RA representative and in general promote the awareness of regulatory and customer requirements throughout the organization. 

Qualifications
To really thrive and be successful in the role and enjoy being a part of Vigmed, we believe that you bring the following experience:
• A minimum of a BSc degree within Life Sciences or Engineering
• At least five years of working experience in a QA and/or RA role in the Medtech and/or Life Science industry
• Experience in audits
• Excellent skills in English and proficiency in Swedish

It will be an advantage if you have experience in the Medtech industry and if you have experience as a leader, responsible for an area of expertise, in line management and/or in a management group. Also if you have knowledge in ISO13485, MDD, MDR and/or FDA. Education and experience in EtO sterilization will also be very useful and seen as a plus. 

We believe that you will bring a teamwork spirit and that you enjoy working in the small company within the bigger company group. You drive and take ownership of your work and execute it with structure, thoroughness and fact driven decision making. You see the value of having a business perspective both in QA/RA but also in what you contribute with in the management group where you make use of you interest in numbers and strategic thinking. 

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Selection and interviews will be ongoing, so we are curious to read your application as soon as possible.

If you have any questions, you are welcome to contact senior recruitment consultant Karolina Andersson at 0705736613 or karolina.andersson@randstad.se. 

About the company
Vigmed is a company within medical devices. We are situated in Helsingborg with a mission to eliminate needle stick injuries within healthcare during intravenous and arterial catherization. Our philosophy when developing the first range of products was to provide the health care workers with familiar, high quality, affordable products, which provide increased protection from needle sticks. Today, we market products for intravenous and arterial catheterization first launched in 2014 – all with an automatic safety function built-in. We have launched the products in all of Western Europe and selected markets outside Western Europe. Our short-term focus is to optimize our existing portfolio and longer term to innovate and establish best-in-class solutions in the market.

During 2017, Vigmed became part of Greiner Bio-One (GBO), which is a privately held, Austrian company within the Med Tech industry. Combining the innovative capabilities and “center of excellence” knowledge within Vigmed with GBOs market position and financial strength is expected to accelerate our growth even further.