Documentation Governance Specialist

1 week ago


Ipoh, Perak, Malaysia Plaxtron Industrial (M) Sdn Bhd Full time
Job Description

We are seeking a highly skilled Documentation Governance Specialist to join our team at Plaxtron Industrial (M) Sdn Bhd. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our documentation in accordance with ISO 13485:2016.

In this role, you will:

  • Control revisions and distribution of Standard Operating Procedures (SOPs), work instructions, and validation documents.
  • Ensure document traceability, approval workflows, and record retention policies are followed.
  • Assist in preparing documentation for audits and regulatory submissions.
  • Train employees on document control processes and best practices.

Requirements

  • A degree in a related field such as Science, Technology, Engineering, and Mathematics (STEM).
  • At least 1-2 years of working experience in a related field is required.
  • Good knowledge of Quality Standards such as ISO 13485:2016 will be an added advantage.
  • Excellent communication skills and interpersonal relationship.
  • Knowledge of software QA methodologies, tools, and processes.


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