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Medical Device Expert
DEKRA Process Safety
·
3.1
India
Full-time
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Job details

Here’s how the job details align with your profile.

Job type

Full-time

Full job description

DEKRA India Pvt. Ltd. is a group company of DEKRA SE. DEKRA is one of the world’s leading professional safety firms, headquartered in Stuttgart, Germany. With over 45,000 employees in 50 countries, DEKRA has been active in the field of safety since 1925.
DEKRA India Pvt. Ltd. with offices in Delhi, Mumbai, Pune and Hyderabad offers an exciting & stimulating work environment and an opportunity for rapid career progression. We provide our employees with regular training, knowledge and the encourage them to implement original and unique solutions. Our compensations match the best in the industry.

Medical Device Expert


DEKRA (India) Pvt. Ltd is looking for competent active medical device auditor .

As Medical Device expert/Auditor your job functions would primarily be
  • Execute audits independently.
  • Are responsible for the assessment of technical files and the auditing of quality systems of your customers (from highly innovative start-ups to large multinationals, both national and international with different kind of active medical devices)
  • Act as a linking pin and maintain frequent contact with your customers, colleagues, external experts, contractors, and authorities.
  • Will travel approximately 60-80% of your time. Most customers (±70%) are in the Asia and within Europe.
  • Experienced in at least one of the following devices categories and areas of expertise: Active medical devices, Active implantable medical devices, soft tissue implant, Cardiovascular devices, Drug device combinations or Animal tissue.
  • Experienced with quality management systems and relevant laws and regulations, at least CE;
Qualification, Experience & Skills required::
  • Bachelor or University degree in life and/or engineering sciences is a must; For example: electrical or electronic engineering, physics or biophysics, biomedical engineering.
  • You have a minimum of 4 years of fulltime work experience in active medical device related industry, including at least 2 years in R&D or QA/RA;
  • Experienced with quality management systems and relevant laws and regulations, at least CE;
  • Project management- or auditing experience is considered an advantage;
  • English language skills are a must.
  • Past relevant experience in a Notified body will be advantageous.
Salary: Negotiable.
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