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Medical Device Auditor

2 weeks ago

Bayan Lepas, Penang, Malaysia Greatech Technology Full time
Medical Device Auditor Job Description

The Medical Device Auditor is responsible for conducting audits and inspections to ensure that medical devices meet regulatory requirements and industry standards. This includes evaluating device design, testing, and manufacturing processes.

Key Responsibilities:
  • Conduct audits and inspections to evaluate device design, testing, and manufacturing processes.
  • Evaluate device performance and safety.
  • Identify and document non-compliance issues.
  • Provide recommendations for improvement.
  • Collaborate with cross-functional teams to implement improvements.
Required Skills and Qualifications:
  • Bachelor's degree in Engineering, Science, or a related field.
  • Minimum 2-5 years of experience in auditing or a related field.
  • Strong knowledge of medical device regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to analyze complex data and develop recommendations for improvement.

Benefits: Competitive salary, comprehensive benefits package, and opportunities for career growth and development.