Quality System Specialist (f/m/d)

bei SzeleSTIM GmbH Wien vor 3 Tagen
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SzeleSTIM is an innovative start-up developing cutting-edge medical technology for chronic pain management, based upon years of scientific and clinical expertise. We help patients to recover and actively shape their lives with our solutions for auricular vagus nerve stimulation.

For our ambitious and fast-growing team with headquarters in Vienna, Austria, we are looking for a

Quality System Specialist (f/m/d)

Full-time, as soon as possible

Your tasks:

  • Preparation and maintenance of QM and regulatory documents for CE approval of our product portfolio
  • Support in setting up a full QM system according to ISO 13485:2016
  • Communication with the notified body and regulatory authorities
  • Support of the R&D team in technical file preparation and maintenance of the risk management file ensuring safe and reliable products
  • Interpretation and preparation of technical, scientific and clinical data for integration into QM and regulatory documents
  • Maintain responsibility for the promotion of quality awareness and continuous improvement throughout the company
  • Organization and support of regular internal audits and supplier audits

Your qualifications:

  • Degree in natural or technical sciences, business administration (BSc, MSc, MBA)
  • Knowledge in implementing regulatory requirements according to the Medical Device Directive (93/42/EWG) and the Medical Device Regulation (EU) 2017/745
  • Knowledge in establishing a QM system according to ISO 13485:2016
  • Experience with collecting and analyzing data (from QMS, SOPs, QS supply chain)
  • At least 2 years professional experience, ideally in the medical device industry
  • Business fluent in German and English
  • Solution-oriented and analytical thinking to understand complex processes
  • Diligent and independent working skills with organizational talent
  • Enthusiastic and inquiring team player with a high degree of flexibility

Our offer :

  • Dynamic role in a motivated team while interacting with R&D, clinical development, product management, sales, and marketing
  • Personal and professional growth in an aspiring start-up
  • The formal minimum annual salary according to the collective bargaining agreement for this position is EUR 31.976,00, willingness to overpay according to the qualifications and experience of the successful candidate

We look forward to receiving your application via mail to jobs@szelestim.com.

SzeleSTIM GmbH
Schlagergasse 2/18
1090 Vienna
Web: http://www.szelestim.com


SzeleSTIM GmbH

Schlagergasse 2/18
1090 Wien

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