QA (Document Control)

Overview

Responsibilities and requirements for a Document Controller role focusing on quality document control, technical documentation, and design and development coordination within a regulatory compliance framework.

Responsibilities

• Assisting in managing quality document control system.
• Preparing and revising Quality Procedures for process owner.
• Issuing documents with identification of "Master Copy", "Controlled Copy", "Uncontrolled Copy" and "For Training Purpose Only".
• Updating and maintaining Document Master List and Records Master List and controlling the distribution of documents within the Quality & Regulatory Compliance Management System (QRCMS).
• Maintaining Master Copy, Controlled Copy and obsolete documents.
• Technical Documentation : Assisting in composing and maintaining Technical Documentation in accordance with EU MDR 2017 / 745 requirements.
• Liaising with OM to obtain latest Technical Documentation periodically.
• Assisting in planning and coordinating Supplier / OM's periodic evaluation audit.
• Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.
• Compiling and maintaining audit files.
• Design and Development : Communicating with OM to assess the feasibility of new designs or changes in existing designs.
• Coordinating with cross-functional teams including Sales and Marketing, QA / QC / RA, to align design and development project objective.
• Preparing design plan and monitoring project timelines.
• Preparing sample requisition form for design and development (SRD).
• Organizing review meetings with team members on every design and development stage.
• Conducting verification and validation on design and development product for compliance.
• Completing and maintaining design and development files.
• Checking, reviewing and verifying labelling of the device packaging to ensure compliance with customer requirements and Applicable Regulatory Requirements.
• Liaising with supplier / designer / OM for artwork amendment and conversion.
• Liaising with customer for artwork amendment and approval.
• Compiling and maintaining Artwork File.
• Participating in Risk Management Team.
• Assigning GS1 barcode number for new item / changed item.
• Assigning lot number for legal manufacturer\'s product.
• Performing other work related function as assigned.

Requirements

Note

High-level recruitment information and boilerplate for EPS Malaysia has been removed to focus on the role specifics and compliance requirements.

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