12. January 2022

New Job Opportunity – Deputy Head QM & RA

To further grow our company, we are looking for a

Deputy Head QM & RA (80-100%)

to join our team as of May, 2022

In this position you

  • Are the lead for the optimization and digitalization of our modular certified QMS, covering active devices, software, non-active devices and in-vitro diagnostics and various geographies.
  • Are the main contact for customer and notified body audits of our QMS.
  • Are the subject matter expert (SME) for risk management and actively take the lead in risk management activities of the company.
  • Will provide input to quality assurance agreements and perform incoming inspections, supplier audits, supplier approvals, supplier complaints as required.

You

  • Have at least 5 years of professional experience in quality management and/or regulatory affairs from the medical device industry.
  • Knowledge of ISO 13485, MDR, IVDD/R, QSR 21 CFR Part 820, and the certification processes for medical devices in Europe and the USA; knowledge of other markets (MDSAP countries) is a plus.
  • Are passionate about process optimizations and lean management.
  • Are a “pro” in digitalization.
  • Have a customer focused approach to coordinate and supervise stakeholders to deliver a high-quality service.
  • Have a pro-active attitude and willingness to bring in ideas and suggestions to support continuous improvement.
  • Have excellent communication and interpersonal skills, ability to gain consensus on key quality decisions, and you value teamwork and find it enriching.
  • Have excellent knowledge of English, written and spoken, and good conversational skills in German.

We offer

  • A new challenge! We have a broad spectrum of products – from software products to active and non-active devices, as well as IVD products – and customers, making this a challenging and fun position!
  • The possibility of working in a motivated team with a common goal – accelerating innovation in the medical device industry.
  • Flexibility – our offices are located in the center of Olten only minutes by foot from the train station; partially working from home is possible.
  • The ability to actively shape and further develop the company with us to reach our common goal.
  • Personal development opportunities in a growing company.

Do you share our vision to facilitate and accelerate medical device product innovation by offering a plug-and-play QMS and outsourced legal manufacturing? If the answer is “YES!” we are looking forward to getting to know you.

Please send your FULL application (CV, motivational letter, work certificates & diplomas) to anne.marie.joller(at)effectummedical.com

Please note that we only accept direct applications (no recruitment companies).