Quality Assurance Specialist

4 days ago


Shah Alam, Selangor, Malaysia Hiredly X Full time

At Hiredly X, we are seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring high-quality standards in medical product manufacturing.

Job Description:

The Quality Assurance Specialist will assist Regulatory Affairs in implementing and maintaining the company's quality management system according to ISO 13485 (2016) and other applicable regulatory requirements.

  • Maintain the company's ISO documentation system
  • Monitor manufacturing processes from a Quality standpoint
  • Review and sign off Device History Record (DHR) documentation
  • Monitor the quality and integrity of all products manufactured at Hiredly X
  • Train employees on GMP and audits as necessary

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.

We offer a competitive salary and excellent benefits package, including comprehensive health insurance, retirement plan, and paid time off.



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