Stellenausschreibungen

Auditors and Technical Experts

Berlin Cert GmbH is a testing and certification body for medical appliances. As an accredited certified body Berlin Cert certifies Quality Management Systems (QMS) according to DIN EN ISO 13485 and as a notified body Quality Assurance Systems according to Directive 93/42/EEC (Annexes II, V or VI). These services are offered to organisations that develop, produce or sale medical devices or components or offer service and installations for such.

In order to expand our spectrum of services, we are looking for

qualified and interested

qualified and interested auditors and technical experts 

for auditing system certifications as well as assessment of special aspects (sterilisation, technologies, EG checks, etc.).

Requirements for auditors

  • An academic degree in the areas of medicine, natural sciences or engineering
  • At least 4 years of full-time work with pertinent experiences in medical devices or pharma industry, science, laboratories or institutions that themselves check or produce medical devices.
  • Of that at least 2 years have to be in the area of quality management/control
  • The participation in at least four trainee-audits with at least 20 days, of which 50% have to be according to EN ISO 13485 – which can be organised via Berlin Cert
  • Provable knowledge of the standards DIN EN ISO 9000 (and following), DIN EN ISO 13485 as well as DIN EN ISO 19011 and the legal regulations for medical products especially of Directive 93/42/EEC
  • acquaintance with the methods of risk management, especially the standard DIN EN ISO 14971
  • Auditor training (successful participation in trainings for conducting audits. At least 40h)
  • Independence according to MEDDEV 2.10/2, section II.2 and EU-Directive 920/2013/EU

Requirements for technical experts

  • An academic degree in the areas of medicine, natural sciences or engineering
  • At least 4 years of full-time work with pertinent experiences, of which at least 2 years have to be in the area of development, production, quality control or assessing to-be-certified medical devices or to-be-assessed (production) technologies (in the relevant fields such as eg. application, bio-compatibility, clinical use, risk management, sterilisation, etc.)
  • Provable knowledge of laws for medical products and the pertinent legal regulations (such as Directive 93/42/EEC) as well as the standards or monographies relevant to production, technology or the field in general
  • Independence according to MEDDEV 2.10/2, section II.2 and EU-Directive 920/2013/EU
  • Furthermore clinical/biological technical experts need at least two years of practical experience with clinical studies or clinical assessments in bio-compatibility
  • We are especially looking for auditors and technical experts in the following fields:
  • orthopaedic and rehabilitation devices (MD 0103)instruments (MD 0106)
  • devices for extracorporal circulation, infusion and haemopheresis (MD 1101)
  • respiratory devices, devices for oxygen therapy incl. hyperbaric chambers and inhalation anaesthesia (MD 1102)
  • devices for stimulation or inhibition (MD 1103)
  • surgical devices (MD 1104)
  • ophthalmologic devices (MD 1105)
  • dental devices (MD 1106)
  • devices for disinfection and sterilization (MD 1107)
  • rehabilitation devices and active prostheses (MD 1108)
  • devices for patient positioning and transport (MD 1109)
  • software (MD 1111)
  • medical gas supply systems and parts thereof (MD 1112)
  • devices utilizing ionizing radiation (MD 1201)
  • monitoring devices of non-vital physiological parameters (MS 1301)
  • monitoring devices of vital physiological parameters (MD 1302)
  • devices utilizing non-ionizing radiation (MD 1402)
  • devices for hyper- and hypothermia (MD 1403)

We offer

  • adequat payment

If you are interested, please contact Mr Martin Tettke , tel.: +49 30 314 25111 or Ms Juliane Schwarz.