Medical Device Quality Assurance Specialist

1 week ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000
Job Summary

We are seeking a seasoned professional to spearhead the implementation and maintenance of a quality management system that ensures our products meet stringent quality, safety, and regulatory standards.

Responsibilities:

  • Develop and implement a comprehensive quality management system (QMS) aligned with international standards such as ISO 13485.
  • Evaluate and ensure compliance with relevant medical device regulations for market entry and ongoing adherence.
  • Manage technical files, regulatory submissions, quality agreements, and internal procedures to optimize efficiency.
  • Collaborate with cross-functional teams to provide QA/RA input and support for design and development activities ensuring compliance from inception.
  • Prioritize risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Analyze device performance in the market, investigate customer complaints and non-conformity, and oversee vigilance reporting.
  • Cultivate supplier relationships and manage supplier quality and compliance effectively.
  • Conduct regular audits and lead initiatives to enhance processes and guarantee adherence to QMS requirements.

Requirements:

  • Demonstrated expertise in global medical device regulations and standards.
  • Exceptional problem-solving and attention to detail skills.
  • Superior communication skills to facilitate coordination with internal departments and external stakeholders.
  • Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous experience in QA/RA within the medical device industry is highly desirable.

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