全职 Quality Assurance Specialist 工作, 薪水 up to MYR 4,000, NRS Global Partners Sdn. Bhd. WP Kuala Lumpur 公司招聘中 - Ricebowl

• Fresh graduates are encouraged to apply.

• Good communication skills in English and Bahasa Malaysia.

• Good organisational skills and attention to detail when handling quality documentation and records.

• Able to prepare, maintain and update quality-related documents accurately.

• Good communication and coordination skills when working with internal departments and external parties.

• Willing to learn quality assurance procedures, audit processes and regulatory compliance requirements.

• Responsible, proactive and able to work independently as well as in a team.

Document Control

• Assist in managing the quality document control system.

• Prepare and revise Quality Procedures for process owners.

• Prepare Document Change Notices (DCN).

• Issue documents with proper identification, including Master Copy, Controlled Copy, Uncontrolled Copy and For Training Purpose Only.

• Update and maintain the Document Master List and Records Master List, and control document distribution within the Quality & Regulatory Compliance Management System (QRCMS).

• Maintain Master Copies, Controlled Copies and obsolete documents.

Technical Documentation

• Assist in preparing and maintaining Technical Documentation in accordance with EU MDR 2017/745 requirements.

• Liaise with OM to obtain updated Technical Documentation periodically.

Audits

• Assist in planning and coordinating Supplier / OM periodic evaluation audits.

• Participate in internal audits, Supplier / OM periodic evaluation audits and external audits.

• Compile and maintain audit files and related documentation.

Design and Development

• Communicate with OM to assess the feasibility of new designs or modifications to existing designs.

• Coordinate with cross-functional teams, including Sales and Marketing, QA, QC and RA, to align design and development project objectives.

• Prepare design plans and monitor project timelines.

• Prepare Sample Requisition Forms for Design and Development (SRD).

• Organise review meetings with team members at each stage of design and development.

• Conduct product verification and validation to ensure compliance with applicable requirements.

• Complete and maintain design and development files.

Artwork Verification

• Check, review and verify medical device packaging labels to ensure compliance with customer requirements and applicable regulatory requirements.

• Liaise with suppliers, designers and OM regarding artwork amendments and conversions.

• Coordinate with customers for artwork amendments and approvals.

• Compile and maintain artwork files.

Other Responsibilities

• Participate in the Risk Management Team.

• Assign GS1 barcode numbers for new or modified items.

• Assign lot numbers for legal manufacturer's products.

• Perform other work-related duties as assigned by the superior.

• EPF Contributions (As Per Malaysian Labour Law).
• SOCSO Contributions (As Per Malaysian Labour Law).
• EIS Contributions (As Per Malaysian Labour Law).