QA Engineer to Vigmed in Helsingborg

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QA Engineer to Vigmed in Helsingborg
Here is an opportunity to come join Vigmed, a Med Tech company in an exciting phase! Do you have an open and straightforward mind-set and want to work with ambitious and dedicated colleagues? Do you have experience from working in the Med Tech field focusing on QA? If these introductory lines fits your ideas for your next step in your carrier, you may be the new QA Engineer we are looking for.

responsibilities.

As a QA Engineer at Vigmed you will contribute with your passion and knowledge within QA. You will be a part of an exciting Med Tech company with a mission to eliminate needle stick injuries within healthcare. Vigmed is a company in the forefront, with focus on development and technology. We are aiming at implementing the new medical device regulations (MDR) to be top on mind toward the most current directives.

The responsibility as a QA Engineer will be to investigate and manage complaints. You will prepare and gather information, run investigations and keep up with internal and external processes. You will also control and do follow-ups on internal deviations, final review of batch records before release of products and handle CAPAs.

Examples of other tasks that will be included in the role;

• Assist in implementing new standards/regulation and/or perform GAP analysis against already present ones
• Support development projects in QA/RA discussions
• Archiving and documentation lists
• Conduct and evaluate risk analyzes


Internally you will work in close contact with the QA/RA Manager Åsa and your other colleagues within Vigmed. On site in Helsingborg, Vigmed is a small company but since its own by the international medical technology company Greiner Bio-One International GmbH you will also have direct contact with your global colleagues. Externally you will work with distributors, production companies and authorities.

This position will give you the possibility to be part of an expanding company with great development possibilities for the right person. You will be given the opportunity to show your drive both independently and in collaboration with your colleagues. To be able to manage the role as a QA Engineer we also see that your foremost personal qualities are accuracy, results-oriented and communicative. If you feel that your professional and personal skills fit into the description, send in your application and come join Vigmed!

qualifications.

You have a BSc or similar within life science and are fluent in English, both spoken and written.



For this role, it is valuable if you have minimum two years of QA experience from medical device industry and experience of customer complaints, deviations, releases and risk analyzes.

We believe that you are familiar with MDR, CAPA handling and that you have experience from working with ISO13485. If you also have knowledge within biocompatibility, validation and have statistical experience, it is meritorious such as fluency in Swedish, Danish or Norwegian.



On a personal level, you possess excellent communications skills with focus on openness and honesty. You prefer to work in a structured way and you have great analytical skills. In addition, we believe you are a self-motivated person with ability to plan and execute activities. You enjoy working in groups as well as individually. As a person, you are accurate and you always strive to deliver results with a top quality.



We place great emphasis on personal qualities for this role.



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

job type.

Permanent position

location.

Helsingborg

applications.

Last day for application is 2019-10-06

More information: Randstad Life Sciences will manage this recruitment. For more information about this position, please contact Recruitment Consultant Emelie Lanner 072-9733382 or emelie.lanner@randstad.se. Please send your application in English via www.randstad.se [ http://www.randstad.se/ ]

We look forward to your application!

about Vigmed.

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. 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 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.



Key words: QA, QA Engineer, Med Tech, Medical device, complaints, CAPA, MDR, Vigmed, GBO