RA QA Manager to Vigmed AB
Vigmed – Eliminating needlestick injuries
Do you want to be a part of a fast growing company and help improve patient focus? Are you ready for an opportunity where you can make a positive difference in many peoples professional lives? Do you want to join a small team, be part of the management team and impact the business and future success? We can offer you the possibility to shape the future of healthcare safety!
Are you up for a role as a game changer?
Vigmed is strengthening the team and is looking for the right candidate to manage the RA and QA activities. The job will be in close cooperation with the rest of the Vigmed team, as well as international cooperation with other RA QA managers in the Greiner Bio-One organization.
Your main responsibilities will be:
Maintaining quality system which must ensure fulfillment of relevant regulatory requirements, e.g. ISO 13485 and MDD
Part of the local management team
Managing complaint handling system and vigilance reporting
Acting as RA QA representative in innovation projects
Reporting the performance of RA and QA to the management team
Ensuring that all relevant partners are audited
Managing labelling and ensuring compliance to regulatory requirements
Ensuring Technical File compliance for new innovation projects and existing product upgrades
As a person, you have a strong drive to create results and an entrepreneurial mindset with excellent problem solving skills. You have a strong team focus and are able to work together with your colleagues in a dynamic, changing environment contributing to business quality and success. You have a good collaborative ability where you can work with all types of people in a prestigeless and consulting manner, combined with good communication skills to be able to motivate your colleagues and partners to work with RA and QA requirements. You are a self starter who focuses on results and you enjoy working in a small company with an opportunity to participate in a broad range of activities and decisions.
Education and background:
Relevant University degree e.g. BSc or MSc.
Minimum 5 years experience from regulatory and quality work within Medical Device
Fluent in Swedish or other Scandinavian language and English, both in written and verbal.
Welcome with your application including cover letter and CV, both in English, to www.mercuriurval.se (ref.nr SE-12580) no later than December 3, 2017. If you have any questions please contact our recruitment consultant, Jonathan Herrlin at Mercuri Urval, phone +46 (0)733 66 75 73.
Vigmed is a company within Medical devices. We are situated in Helsingborg with a mission to eliminate needle stick injuries within healthcare. 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 have marketed 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. We expect 2017 sales to increase by more than 50 percent compared to last year. Our short term focus is to establish ourselves in the market with existing or upgraded products, and long term to innovate and launch even better solutions than what is present in the market today.
During 2017, Vigmed became part of Greiner Bio-One (GBO), which is a privately held, Austrian company within the medtech 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.