Quality & Risk Manager in a Norwegian globally leading medical-technical company

Will you lead risk management and validation processes and develop our quality systems for the production of advanced medical devices that save lives?

The main responsibilities for the position will be:

• Lead risk management of products and product-related processes
• Lead validation of processes and non-product computerized systems

The main tasks are:

• Manage and coordinate activities to identify, estimate and control risk related to Medistim’s products
• Manage and coordinate validation processes
• Contribute to improved work processes in accordance with the framework of the medical device regulations
• Participate in 1st, 2nd and 3rd party audits

We are looking for someone with a Bachelor- or Master's degree in engineering or natural sciences, and a minimum of 5 years of experience in manufacturing and/or QA within a regulated industry, preferably in medical devices or pharmaceuticals. Experience from automated production lines is an advantage. You should have good knowledge of ISO13485 or equivalent international standards for medical devices, as well as deep knowledge of regulatory requirements for medical devices, in particular within risk management and validation.

It is important to be experienced in project management and -work. You must have an analytical mindset, and the ability to execute and get things done.

The position requires close cooperation with the whole organization, so you need good communication and cooperation skills. You must be fluent in English and Norwegian, both oral and written. You have to be familiar with the use of electronic tools, especially digital QMS tools, and open-minded in meeting with new programs.

As our Quality and Risk Manager, you will get a central role in the QA&RA department, in an innovative, globally leading medical-technical company with both headquarters and manufacturing in Norway. We believe this is a meaningful job, helping to extend and improve the lives of cardiovascular patients around the world. With us, you get good professional and personal development opportunities, and you become part of a pleasant, informal and inclusive working environment, characterized by competent employees with high ambitions. The role reports to the VP of Quality Assurance & Regulatory Affairs.

The position cooperates closely with our production department, so the place of work is preferably at our production site in Horten. Location at the head office in Oslo may also be relevant, but then regular travel to Horten must be expected.

For further information or answers to questions about the position, contact VP of Quality Assurance and Regulatory Affairs, Tone Veiteberg by phone +47 40066660.

The application deadline is as soon as or no later than the 28th of August 2022. Applications will be processed consecutively, and are treated confidentially.