Software Quality Engineer
Description
Salary: RM 3,800 – RM 5,700 per month
Review, verify, and approve all Equipment Qualification documentation to ensure completeness and accuracy.
Partner with engineering, operations, and cross-functional teams to investigate, troubleshoot, and resolve quality issues related to non-device software and any discrepancies arising during qualification activities.
Ensure all software quality processes adhere strictly to internal standard operating procedures (SOPs), applicable global regulatory requirements, and recognized industry standards.
Support vital Software Quality processes, including Non-Conformance Evaluation Process (NCEP), Corrective and Preventive Actions (CAPA), and comprehensive risk management activities.
Actively participate in project meetings, design reviews, and technical discussions related to non-device software validation and lifecycle management.
Requirements
Bachelor’s degree in an Engineering discipline, Computer Science, or a related technical field of study.
Minimum of 2+ years of professional experience in Quality Assurance (QA), Quality Control, or a related technical role within the medical device or highly regulated manufacturing industry.
Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards and FDA 21 CFR Part 820 and FDA 21 CFR Part 11