Medical Product Quality Manager

5 days ago


Shah Alam, Selangor, Malaysia Hiredly X Full time

Hiredly X is a leading manufacturer of medical products, and we are seeking a highly skilled Medical Product Quality Manager to join our team.

Key Responsibilities:

The Medical Product Quality Manager will be responsible for monitoring and sustaining the quality and integrity of all products manufactured at Hiredly X. This includes reviewing and signing off QA release forms for all commercial products.

  • Assist Regulatory Affairs in implementing and maintaining the company's quality management system
  • Take ownership of and maintain the company's ISO documentation system
  • Gain familiarity with manufacturing processes, then monitor these processes from a Quality standpoint
  • Coordinate and maintain the CAPA and NCR systems for the company

To be successful in this role, you must have a bachelor's degree in a relevant subject area, such as science or engineering. At least 4 years' work experience in the QA field is required, with experience and familiarity with ISO 13485 Quality Systems. Medical device and cleanroom familiarity is preferred. Experience with internal and external audits is also required.



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