Kerja Sepenuh Masa Validation Engineer (Quality Engineering ), Gaji tinggi MYR 5,500 di KAIFA TECHNOLOGY MALAYSIA SDN BHD Johor - Maukerja

Responsibilities:

- Plan and perform validation activities for equipment, processes, systems, software, and products. - Prepare, review, and maintain validation protocols, reports, CAPA records, and related quality documents. - Support validation activities, including risk assessment, testing, deviation handling, and validation closure. - Investigate quality issues such as nonconformances, deviations, customer complaints, and audit findings. - Coordinate with Project and others SME for Change Management Process - Conduct root cause analysis using appropriate problem-solving tools. - Develop, implement, and monitor corrective and preventive actions (CAPA). - Verify and document the effectiveness of CAPA actions. - Ensure validation and CAPA activities comply with quality management system requirements and applicable standards. - Maintain accurate records and proper document control for validation and CAPA activities. - Collaborate with cross-functional teams to support quality improvement initiatives.

Requirement :

- Minimum 2–3 years of relevant experience in validation, quality assurance, quality engineering, CAPA management, manufacturing engineering, or a related technical field. - Bachelor’s degree in Engineering, Science, Quality Management, or an equivalent technical discipline. - Experience in planning, executing, documenting, and reviewing validation activities for equipment, processes, systems, software, or products. - Experience in investigating non conformances, deviations, customer complaints, audit findings, quality issues and change management. - Knowledge of validation principles, CAPA processes, root cause analysis tools, risk management, and continuous improvement methodologies. - Familiarity with quality management systems and applicable regulatory or industry standards is preferred. - Knowledge of Good Documentation Practices (GDP) and data integrity principles. - Strong analytical, problem-solving, communication, and documentation skills. - Familiarity with quality management systems ISO 13485 and applicable regulatory or industry standards is preferred.

Pay: RM4,000.00 - RM5,500.00 per month

Work Location: In person