Client Background:

Our Client is a leading supplier with strong credentials in the latex dipped products industry, Male latex condoms, Personal Lubricant, Prophylactic Oral Dam, Transducer Probe Covers, Dental Dams, Resistance / Exercise Bands.

Industry: Trading

Location: Kuala Lumpur

Headcount: 1

Tenure: Permanent

Remuneration: Basic + Benefits

Responsibilities:

· Documents Control:

· 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 Managemetn 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.

· Audits:

· 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 meeting with team members on every design and development stages.

· Conducting verification and validation on design and development product for compliance.

· Completing and maintaining design and development files.

· Artwork Verification:

· 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.

· Others:

· 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:

· At least Diploma/ Degree in Engineering field.

· Min 1 year of working experience.

· Must be able to work in Bandar Tasik Selatan area.

· Ability to work in team work and independently.