01. April 2021

We are hiring

Effectum Medical is a young company that is breaking new ground in the areas of quality management and regulatory affairs in the medical device industry. Our vision is to facilitate and accelerate medical device product innovation by offering an affordable, outsourced quality management system (QMS) and legal manufacturing. Our customers are start-ups, as well as global medical device manufacturers.

 

To further grow our company, we are looking for a

Quality Manager (80-100%)

 to join our team.

In this position you

  • are responsible for the maintenance of our QMS
  • are the key contact to our Notified Body and responsible to manage all interactions
  • are responsible for the complaint management activities
  • are responsible for management of our CAPA process and activities
  • are a key person for NB audits and customer audits, initiate and lead internal audits and participate in supplier audits, as required
  • release and reject products (incoming inspection)
  • have the overall responsibility for the change control process
  • review and update regulations, norms and standards and integrate these into our QMS
  • monitor and report the effectiveness of QMS and communicate required improvements with an action plan
  • perform quality-relevant PMS activities
  • increase the awareness of quality requirements throughout the organization

You have

  • at least 3 years of professional experience in quality management in the medical devices industry
  • knowledge of ISO 13485 and MDR requirements are a must; knowledge of IVDD/R and QSR 21 CFR Part 820 would be an additional benefit
  • you are a team player with excellent communication and interpersonal skills and the ability to gain consensus on key quality decisions
  • you are pro-active and willing to bring ideas and suggestions to support continuous improvement and to establish a successful evolution process
  • excellent knowledge of English, written and spoken, and good conversational skills in German

 We offer

  • the possibility of working in a motivated team with a common goal – accelerating innovation in the medical devices industry
  • flexibility – our offices are located in the center of Olten, 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 an affordable, outsourced quality management system (QMS) and legal manufacturing? If the answer is “YES!” we are looking forward to getting to know you. Please send your application to anne.marie.joller(at)effectummedical.com