QM Process Professional Job in Aalborg, Nordjylland Denmark

Neurodan
QM Process Professional
Aalborg Area, Denmark

Neurodan A/S is part of the Otto Bock Group, a global leader in exoprosthetics and renowned manufacturer of wheelchairs and orthoses. The headquarter of the Otto Bock Group is in Germany, with affiliations in 36 countries. Worldwide Otto Bock has more than 4.000 employees. Neurodan develops medical devices within neurostimulation. Currently one product is on the market, the drop foot correction system ActiGait®. Drop foot is a high incidence and high prevalence complication typically following cerebral stroke.

As the QM Process Professional you will be taking the lead on updating and maintaining Neurodan's Quality Management System and its standard work procedures. You will support Neurodan's process / SOP owners in systematically finding process deficiencies and improve and optimize company processes. Furthermore you will support / run projects which are of particular importance and fall into the responsibility of Quality Management or Regulatory Affairs. In addition you will define and develop Q-objectives. Depending on experience and background you will also be process owner within one or more areas (e.g. Vigilance).

You hold a degree in technical (engineering), life sciences, or a related field. You have a minimum of three years relevant experience and are fluent in English. With your experience in project management you are able to apply different tools to ensure continuous improvement and effective planning. With your strong interpersonal skills and persistent manner you facilitate and consult project teams on SOPs and quality matters etc.

You have working knowledge of QM Systems and ISO 9001 and ideally you also have experience as a QMS auditor, with ISO13485, cGMP and/or QSR. Preferably you are familiar with EU regulations/directives, FDA regulations, EU regulations/directives, Health Canada regulations, and other international laws and regulations.

Knowledge in specific life science processes such as Vigilance, Clinical Evaluation, Post Market Feedback and/or Risk Management would be an advantage. Additionally you have experience from highly regulated industries such as medical devices, pharmaceuticals, aerospace, weapons, food, etc.


We are interviewing ongoing so please
apply as soon as possible.
For further information please contact
Recruitment Consultant Sidse Holten
+45 2240 5776