Medical Device Quality Assurance Specialist

2 days ago

Navi Mumbai, Maharashtra, India beBeeQualityAssurance Full time ₹ 60,00,000

Job Title: Medical Device Quality Assurance Specialist

This role is responsible for ensuring the quality of medical devices, from development to delivery. The successful candidate will have a deep understanding of ISO 13485 and ISO 9001 standards and be able to implement processes to meet these requirements.

  • A strong background in quality assurance in the medical device industry is essential, with at least 5 years of experience.
  • Familiarity with regulatory compliance such as US FDA is desirable.

Responsibilities:

  • Implement and maintain quality management systems and procedures.
  • Conduct internal audits to ensure compliance with ISO 13485 and ISO 9001.
  • Develop and implement training programs for employees on quality management systems and procedures.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Ensure that all lab equipment is validated and calibrated according to company procedures.
  • Responsible for maintaining clean room standards and audit compliance.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering or a related field.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Able to work independently and collaboratively as part of a team.

About the Company:

This is a challenging opportunity for a motivated individual who is passionate about quality assurance in the medical device industry. If you are looking for a dynamic work environment where you can grow and develop your career, we encourage you to apply.

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