Quality Assurance Professional

1 week ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Senior Quality and Regulatory Expert

About the Job:

Our mission is to help people live longer, healthier lives by expanding their health spans. We believe that the human body is the most important frontier in the 21st century.

We are looking for a highly organized and detail-oriented Senior Quality and Regulatory Specialist to support our ongoing operations and quality management system (QMS) improvement initiatives.

This role requires a hands-on professional who is passionate about ensuring compliance and driving quality. The ideal candidate will have experience managing QMS, leading audits and inspections, and analyzing trends in quality data.

The successful candidate will also possess excellent communication and collaboration skills to work effectively with various teams and external parties.

Key Responsibilities:

  1. Manage the QMS to ensure efficiency and compliance with company procedures and related standards.
  2. Lead QMS compliance with internal procedures and external regulations, including 21 CFR Part 820, ISO 13485, and EU MDR.
  3. Investigate and resolve corrective actions and non-conformances, ensuring documentation complies with relevant standards.
  4. Analyze trends in quality data and identify systemic issues to contribute to continuous improvement initiatives.

Required Skills and Qualifications:

  • In-depth knowledge of medical device regulations, including 21 CFR Part 820, ISO 13485, and EU MDR.
  • Proven experience in managing and improving QMS, with a strong grasp of document control processes.
  • Excellent auditing, CAPA/NC management, and data analysis skills.
  • Strong analytical and problem-solving skills, with the ability to manage deliverables and track corrective actions.
  • Excellent communication and collaboration skills to work effectively with cross-functional teams.

What We Offer:

A collaborative and innovation-driven work culture. Exposure to global healthcare markets and cutting-edge medical solutions.

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