Chief Medical Device Quality Specialist

2 days ago


Bengaluru, Karnataka, India beBeeQualityEngineer Full time ₹ 1,50,00,000 - ₹ 2,10,00,000
Job Summary

The Lead Quality Engineer is responsible for supporting new product development and maintenance through the application of quality engineering skills for medical devices.

Main Responsibilities
  • Collaborate with cross-functional teams to ensure design control projects are completed successfully.
  • Prioritize experience in Sterilization processes to ensure compliance with industry regulations.
  • Develop and lead risk management activities to mitigate potential risks.
  • Support the creation of specifications, design, and test methods for new products to ensure accuracy and reliability.
  • Maintain effective communication with manufacturing teams during development stages.
  • Apply technical principles and quality sciences/tools consistently to drive improvement.
  • Verify that all design control and production/process control projects meet regulatory requirements.
Key Qualifications
  • Strong working knowledge of medical device regulations and practices (ISO13485, ISO 14971, FDA).
  • Extensive experience in Design Control principles.
  • Demonstrated understanding of statistical concepts and regulatory requirements.
  • Class II/III medical device expertise.
  • Knowledge of six sigma methodology and ASQ certifications (CQE/CQA).
Essential Requirements
  • Disciplined documentation practices.
  • Excellent team player with strong communication skills.
  • Able to work independently with minimal supervision.

Critical thinking and problem-solving skills required. Excellent written and verbal communication skills essential.



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