Medical Device Quality Lead for Accessories

6 days ago


Bengaluru, Karnataka, India Siemens Technology Full time
About the Role

The Medical Device Quality Lead for Accessories will be responsible for ensuring the quality and regulatory compliance of medical device accessories. This individual will work closely with cross-functional teams to develop and implement quality management systems, ensuring that all accessories meet the necessary regulatory requirements.

Main Responsibilities
  • Develop and maintain quality management systems for medical device accessories
  • Collaborate with cross-functional teams to ensure that all accessories meet regulatory requirements
  • Provide guidance and support to internal stakeholders on quality and regulatory matters
Skills and Qualifications
  • Strong understanding of EU MDR 2017/745 and ISO 13485 requirements
  • Experience in managing quality management systems, document control, and change management
  • Knowledge of risk management principles and post-market surveillance processes
  • Excellent communication and collaboration skills


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