Kerja Sepenuh Masa, Software Quality Assurance Engineer di Manpower Malaysia Federal Territory - Maukerja

Job Responsibilities:

• Review and approve equipment qualification documentation
• Work closely with cross-functional teams to resolve quality issues related to non-device software and address any discrepancies during qualification
• Ensure compliance with company procedures, applicable regulatory requirements, and industry standards
• Support Software Quality processes including NCEP/CAPA and risk management
• Participate in meetings and discussions related to non-device software validation

Requirements:

• Bachelor’s Degree in Engineering or a related field
• Minimum 2 years of experience in Quality, QA, or within the medical device industry
• Knowledge of Quality System Regulations (QSR), Medical Device Regulations, and ISO standards (e.g., ISO 13485)
• Familiarity with validation processes, documentation, and compliance requirements
• Strong problem-solving skills and ability to work in a cross-functional team environment