Job Description

About the job QA Executive (Manufacturing based in Kuala Lumpur)

• Assisting in managing quality document control system.
• Preparing and revising Quality Procedures for process owner.
• Preparing Document Change Notice.
• Issuing document 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.
• Assisting in composing and maintaining Technical Documentation in accordance with EU MOR 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.
• 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 (SRO).
• Organizing review meeting with team members on every design and development stages.
• Conducting verification and validation on design and development product for compliance.
• Checking, reviewing and verifying labelling of the device packaging to ensure compliance with customer requirement 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 I changed item.
• Assigning lot number for legal manufacturer's product.
• Performing other work related functions as assigned by superior.

• Minimum a Diploma in any field.
• At least 2 years of QA experience from any industry.
• Candidate from manufacturing industry are added advantage.
• Good in English (Spoken & Written)
• Working hour: Mon-Fri (9am-5.30pm)