QA Executive (Manufacturing based in Kuala Lumpur)

Talent Recruit; Kuala Lumpur; On-site; MYR 36,000 - 60,000; Full time

Job summary

Talent Recruit is seeking a QA Executive for a manufacturing operation based in Kuala Lumpur. You will assist in managing the quality document control system, preparing and revising Quality Procedures for process owners, and issuing controlled documents in accordance with internal standards.

You will coordinate audits, maintain master lists, and liaise with cross-functional teams and suppliers to ensure regulatory alignment and smooth Design/Development workflows at all stages.

Qualifications

• Diploma holders eligible; 2+ years QA experience required.
• Experience in manufacturing QA preferred.
• Familiar with regulatory and quality systems.

Responsibilities

• Assist in managing the quality document control system.
• Prepare and revise Quality Procedures for process owners.
• Coordinate internal and external audits.
• Maintain Master List and control distribution of documents.
• Liaise with suppliers and design teams on documentation.

Skills

Document control

Quality procedures

Audit coordination

Cross-functional liaison

Education

Diploma

Job description

QA Executive (Manufacturing based in Kuala Lumpur)

Job Openings QA Executive (Manufacturing based in Kuala Lumpur)

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

Job Description

• 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.

Requirement

• Minimum a Diploma in any field.
• At least 2 years of QA experience from any industry.
• Candidate from manufacturing industry are added advantage.