Documentation Governance Specialist
1 week ago
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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