Design Quality Assurance Specialist

6 days ago

Pune, Maharashtra, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Quality Engineer - Medical Devices

Job Description:

As a Quality Engineer, you will be responsible for ensuring the development and manufacturing of medical devices meet the highest quality standards.

Key Responsibilities:

  • Ensure compliance with relevant regulations and standards, such as EU MDR, US FDA 510(k), and ISO 13485.
  • Develop and implement quality management systems, including risk management and post-market analytics.
  • Collaborate with cross-functional teams to design and develop high-quality medical devices.
  • Perform independent technical assessments and root cause analysis to identify and resolve quality issues.
  • Communicate effectively with stakeholders to ensure timely and effective resolution of quality-related issues.

Requirements:

  • 6+ years' professional experience in medical device regulatory, quality management, and product development.
  • Expertise in interpreting and implementing medical device standards and guidelines.
  • Knowledge of medical device QMS (e.g., ISO 13485, MDSAP, EU MDR, Risk Management).
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration skills.

Benefits:

  • Opportunity to work on high-profile medical device projects.
  • Collaborative and dynamic work environment.
  • Professional growth and development opportunities.

Additional Information:

This is a challenging and rewarding role for an experienced Quality Engineer looking to make a difference in the medical device industry.

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