Technician, Quality Operations

Insulet

Gelang Patah, Malaysia
Qa acceptance activities
In-process quality assurance testing
Environmental monitoring
The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations

Job Summary

  • The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.
  • Perform lot qualification testing of production release to maintain customer supply.
  • Participate in continuous improvement into the investigational process to yield more efficient and robust processes.

Matching Summary

The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.

Skills & Requirements

Must-have

  • QA Acceptance activities
  • in-process quality assurance testing
  • environmental monitoring
  • microbiology testing
  • Maintain inspection records
  • data entry MES/SAP system
  • Good Documentation Practices

Nice-to-have

  • continuous improvement investigational process
  • team player
  • communicate effectively

Key Requirements

  • Minimum Diploma in Engineering or Science
  • At least 3 years of hands-on experience
  • quality operation, inspection and testing
  • medical device industry experience
  • Microbiology testing experience
  • test method validation and GR&R experience
  • ISO13485 requirements understanding
  • GLP knowledge
  • Microsoft Excel, data entry, analytical skills
  • Proficient in English and Malay

Work Rights

Not specified

Tailored Resume

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