Quality manager SonoClear AS

The Trondheim area in Central Norway is considered one of the top medical ultrasound clusters in the world, with several prominent institutions and companies. Surgeons and engineers from St. Olavs Hospital, NTNU (Norwegian University of Science and Technology) and the research foundation SINTEF has collaborated for more than 20 years to develop new techniques for intraoperative ultrasound guided surgery.

SonoClear AS was established in 2016 as a spin off from the Ultrasound and Image-Guided Therapy Centre in Trondheim, and is an innovation and research-based company with key competence within medical ultrasound technology and neurosurgery. SonoClear AS is developing an acoustic coupling fluid (ACF) to be used in ultrasound guided neurosurgery. The overall objective is to enhance image quality during brain tumor resection, providing the surgeon with improved decision support.

To lead the contunied development of the company quality management system and drive the execution of quality strategies in compliance with European and US standards, we seek a Quality Manager.

Main responsibility:

The Quality manager will proactively develop, lead and drive the execution of the company Quality system. In this role, the Quality manager will have overall responsibility for the continued development of company Quality Management System (QMS) towards certification according to ISO 13485:2016 and compliance with the EU Medical device regulation and US Code of federal regulations, including managing and improving all aspects of the QMS.

The Quality manager is also responsible for the Quality Assurance of the product during development of the product. The responsibility will be extended to Quality Assurance during manufacturing, in line with the future product realization set-up.

Tasks:

·       Development of Quality management system towards ISO 13485:2016 certification

·       Develop and execute Quality design and Quality assurance strategies for product development and Life cycle management of existing and new products.

·       Effectively create and support process enhancement initiatives to maintain an environment of continuous Quality improvement, focus and adherence throughout the organization.

·       Provide effective leadership for support, training and guidance to all company personnel, in Quality related topics.

Professional Competences

·       Extensive experience in medical device quality or regulatory affairs in a medical device, pharmaceutical or life sciences technology driven company.

·       Experience in strategic planning and collaboration in executive and key operational groups.

·       Experience in working within a quality management system

·       Proven record of leadership roles in quality/regulatory/clinical oriented organizations or teams, with global/international reach.

·       Proven record of implementation of strategic quality enhancement or regulatory growth initiatives.

·       Knowledgeable of the phases in the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.

·       Knowledgeable in Microsoft Office 365 programs and tools.

Desired: 

·       Training and/ or working knowledge of ISO13485, 21CFR820 and MDD 93/42/EEC or ideally MDR2017/745.

·       Experience in clean-room production for pharmaceutical products or medical devices.

·       Knowledgeable in chemistry.

Personal Competences

·       High level of personal and professional integrity.

·       Strong work ethics and quality mindset.

·       Ability to lead, influence and work within a cross-functional team environment.

·       Assertive and take-charge mentality with a strong results orientation, positive attitude and a sense of urgency to get things done.

·       Excellent communications and presentation skills. The company working language is English. 

Education

Higher degree (at least Master) in engineering, biotechnology, pharmacy, chemistry or any other relevant life science. Applicants with other degrees should be able to demonstrate more than 5 years of relevant industry experience.

Benefits

As Quality manager you will have the opportunity be a vital part of a medical device start-up, aiming to operate in a global market. The company office is located in central Trondheim (Pirsenteret), as part of the CoFounder TechHub. You will work in a highly dynamic environment, influenced by a “can-do” atmosphere.

SonoClear AS offer competitive terms and conditions.