Highly Experienced Senior Medical Device Specialist

2 days ago


Rajkot, Gujarat, India beBeeDevice Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Senior Device Engineer

About the Role:

We are seeking a highly experienced senior device engineer to fill this exciting opportunity.

This position requires a seasoned professional with a strong background in medical devices and quality management.

Main Responsibilities:
  1. Develop Quality Management Systems: Implement quality management systems that meet international standards (ISO 13485, MDD, IMDR).
  2. Audit Medical Devices: Conduct audits and assessments of medical devices to ensure compliance with regulatory requirements.
  3. Risk Mitigation: Work collaboratively with cross-functional teams to identify and mitigate risks associated with medical devices.
  4. Stay Updated: Stay up-to-date with the latest regulations and industry developments, applying this knowledge to improve our processes and products.
Requirements:
  • 10+ years of experience in a relevant field, including research and development, manufacturing, quality management, and regulatory affairs.
  • 5+ years of experience in quality management is essential.
  • Strong knowledge of ISO 13485, MDD, IMDR, and risk management principles.
  • Experience with EN ISO 14971 and sterilization processes.
  • Excellent communication and teamwork skills.
What We Offer:

We offer a dynamic and challenging work environment, opportunities for growth and professional development, and a competitive compensation package.



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