Full Time Quality Assurance Executive Jobs, Salary up to MYR 4,000 in AUREUMAEX MEDISAFE (M) SDN. BHD. Negeri Sembilan - Maukerja

RESPONSIBILITIES

• Support the implementation, maintenance, and continual improvement of the ISO 13485 Quality Management System.
• Ensure QMS procedures, SOPs, and work instructions are established, implemented, and maintained.
• Monitor compliance with ISO 13485, regulatory, and customer requirements.
• Prepare, review, update, and control quality documents including SOPs, work instructions, forms, and records.
• Ensure proper document control, revision control, and record retention in accordance with QMS requirements.
• Coordinate non-conformance handling for incoming, in-process, and finished products and monitor CAPA effectiveness.
• Conduct internal quality audits and support external audits by certification bodies, customers, and regulatory authorities.
• Support risk management activities in accordance with ISO 14971.
• Support customer complaint handling and feedback analysis.

QUALIFICATION: Bachelor’s degree or diploma in Engineering, Science, Quality Management or any related field.

EXPERIENCE

• Knowledge of Quality Management Systems (QMS) and ISO 13485 requirements.
• Experience in documentation control, non-conformance handling, and CAPA activities.
• Experience in medical device or regulated manufacturing environment is preferred.

Pay: RM3,000.00 - RM4,000.00 per month

Work Location: In person