QA RA specialist

This is your chance to get away from your boring position at a standard medical company and take the plunge in a 6 year old Dutch start-up company that has made its first inroads into the high-tech world of Hearing  Aids. Time for you to take on some real responsibility in quality  and  regulatory affairs. We face many challenges and the road is not smooth. But the team consists of 25 creative and committed people who are changing the world as we speak. Our first product “the Q” has rocked the hearing aid market and our product pipeline is filled with more exciting aids – all patented. Our challenge is to grow out of the start-up phase into being a stable growth company.  We have entities in NL and the US; we sell in more than 25 countries; we are a medical equipment company with all the regulatory compliance issues that come with that. 

This is your chance to prove that you can actually apply what you have learned in a more complex environment – being  responsible  for QA and RA at ExSilent.
 
Role of the QA/RA Specialist
The QA/RA Specialist is end-responsible for all quality and regulatory aspects of our processes and products. Both in the Netherlands and in the US. 
 
Activities:
  • Maintenance of the Quality Manual
  • Management of complaints,  CAPA’s and deviations
  • Prepare and execute Management Review
  • Execute  internal and external audits
  • Approval artwork
  • Document control
  • Coordinate Notified Body Audits
  • Submission of technical file to Notified Body
  • Primary contact to Competent Authorities
  • Control of technical file
  • Review technical documentation
  • Write STED, Risk Analysis and ERC
  • Coordinate and control design projects
  • Execute gap analysis
  • Registration of products in different countries
  • Maintenance of registration of products in several countries
 
Qualifications:
  • Must have 3+ years experience in QA and RA in the medical device industry
  • Preferably in the Hearing Aid industry
  • Good knowledge of the MDD (93/42 EEC), ISO 13485
  • Experience in control of the technical files
  • Knowledge of Clinical Reviews and PMS
  • Experience with submissions 
  • Experience with contact with a Notified Body
  • Experience in maintaining a QMS 
  • Knowledge of registration (preferably BRIC counties)
  • Preferably knowledge of 21CFR820, SOR/98 282, ISO 10993 series, ISO 14971 and MEDDEV’s
  • Experience in the or Optician industry is an advantage 
  • Master of Science  or comparable education (physics, medicine, chemistry, biology, or another beta study)
  • Strong communication skills 
  • Good project management skills to coordinate development projects 
  • Fluent in English. Both written and oral is essential. Dutch, German and Spanish also preferred
  • Team player
  • Strong personality with own opinion
  • Dedication and responsibility
  • Helicopter view and an eye for detail
 
We offer:
An exciting and variable job that demands responsibility and will bring satisfaction
A good and pleasant working atmosphere
A chance to write history with a high-tech company
The chance to do something good for people. We improve the lives of many
The chance to have real impact
 
Please send your CV (and optional cover letter) to Jolanda Blankendaal
 
ExSilent B.V.
Overschiestraat 63
1062 XD  Amsterdam
The Netherlands
tel: +31 (0)20 675 1004
 

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