Medical Device Assurance Specialist

4 days ago


Palakkad, Kerala, India beBeeDevice Full time ₹ 12,00,000 - ₹ 15,00,000
Job Title: Senior Device Engineer

We are seeking a highly skilled Senior Device Engineer to spearhead medical device audits and assessments, ensuring compliance with relevant regulations.

Responsibilities:
  • Conduct thorough audits of medical devices to guarantee adherence to ISO 13485, MDD 93/42/EEC, and IMDR standards.
  • Collaborate effectively with cross-functional teams to achieve shared goals.
  • Utilize EN ISO 14971 to proactively identify and mitigate risks associated with medical devices.
  • Possess in-depth knowledge of non-active devices and sterilization processes.
Requirements:
  • At least 10 years of professional experience in the medical devices industry or related fields.
  • A minimum of 5 years of relevant experience in quality management is essential.

To succeed in this role, you should be a motivated and detail-oriented individual who can drive our team's success. If you possess the necessary skills and qualifications, please submit your updated CV for consideration.



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