Auditor/Product Expert for Active Medical Devices

AUDITOR/PRODUCT EXPERT FOR ACTIVE MEDICAL DEVICES

Location: Germany

My client has a mission to achieve sustained development of safety and quality in order
to meet the challenges arising from the interaction between man, technology and the environment.
As a leading provider of technical services worldwide now they are hiring:
Auditor/Product Expert for Active Medical Devices
Language requiremnt: Deutsch – C2
Location – NRW, 70% travel

Requirements:

  • Examining, evaluating, making medical devices safe – what to expect:  Regulatory bodies, hospitals, health care practitioners and patients expect the devices used to treat and heal illnesses and injuries to be safe and to perform as promised.  Join us in our mission to assist our customers in producing and operating the most effective, technologically sophisticated and safest products for the medical sector.  As an Auditor, you ensure that our customers’ active medical products meet the highest safety standards. In detail, that means:

    • You primarily conduct audits based on the EC Directive 93/42/EC, the MDR, the standards EN ISO 13485, ISO 9001 and according to international schemes such as MDSAP and TCP.

    • You compile reports and audit documentation.

    As a Product Expert, you support our medical technology customers with your professional expertise:

    • You evaluate active medical products in accordance with European guidelines and standards.

    • You are responsible to review technical documentations of selected product groups in the active medical device area in your field of expertise, such as dental medical devices, active surgical, ophthalmic or electrophysiological devices.

    Profile of successful candidate:

    • Degree course in natural sciences or engineering

    • At least 2 years professional experience in development, production, quality assurance, regulatory affairs or quality management of medical devices

    • Four years of professional experience is a plus, which can be partially substituted if you’ve previously worked for us.

    • Auditor training is a plus

    • Knowledge of relevant guidelines, norms, and standards as the EN 60601-1ff series as well as product-specific standards;

    • Fluent in your second language English

    • Local and international business trips are required (depending on country specific conditions up to 70% per month), and a Class B driver’s license

  • Sprachanforderungen
    Deutsch – C2 , Englisch – C2

If you want to apply for this position, please send your updated CV along with your
salary expectations to tanya@personalitymeasurement.com

Please, apply only if you are eligible to work in EU.

Tanya Todorova Written by: