With development centres and manufacturing sites all around the world, and a presence in more than 130 countries, the company we are representing holds a broad portfolio of medicinal products ranging from oral solids, gels and patch technologies, to complex injectables, and inhalers. A new and exciting position has just become available for a QA Device Manager to join their Production team in Austria.
A day''s work would typically cover
* development, implementation and maintenance of quality processes / SOPs in the medical devices industry based on ISO 9001 and ISO 13485
* implementation of risk management based on ICH Q9 and ISO 14971
* Independent planning, organisation and implementation of complete audit in support of quality concerns (eg, deviations, complaints)
* participation in QA meetings to interface with the general development of quality-related topics for continuous improvement.
Upon successful completion of a degree in science (pharmacy, biology, microbiology, chemistry), you will have already gained professional experience in a GMP regulated environment or in the medical devices sector, ideally in a position in quality assurance, development or production. As part of that you will be familiar with working to the Medical devices Directive and ISO 13485 as well as international equivalents. A knowledge of the Pharmaceutical Development life cycle would also be useful.
Very good English skills are needed for this role, while German would be beneficial.. Some travel may be required.
This is a new role with a company that is both well established and growing, and with huge potential to progress.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at firstname.lastname@example.org