QA Engineer

Key Responsibilities

• Ensure compliance with ISO 13485, GMP, FDA 21 CFR Part 820, and company Quality Management System (QMS).
• Monitor manufacturing processes to ensure product quality meets customer and regulatory requirements.
• Lead investigations on product non-conformances, customer complaints, and manufacturing deviations.
• Coordinate and monitor Corrective and Preventive Actions (CAPA).
• Review and approve quality documents including SOPs, work instructions, inspection standards, validation protocols, and engineering change documentation.
• Support internal, supplier, and external audits, including customer and regulatory inspections.
• Analyze quality data, identify trends, and recommend process improvements.
• Participate in risk management activities and process validation.
• Work closely with Production, Engineering, R&D, Supply Chain, and Manufacturing teams to resolve quality issues.
• Support New Product Introduction (NPI) by ensuring quality requirements are incorporated into manufacturing processes.
• Ensure calibration, inspection, and testing activities are performed according to established procedures.
• Prepare quality reports, KPIs, and documentation for management review.
• Train employees on quality procedures, regulatory requirements, and good documentation practices (GDP).
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Job Requirements

• Bachelor's Degree in Engineering or related disciplines
• Minimum 2–5 years of Quality Assurance experience in a manufacturing environment.
• Experience in medical device, healthcare, pharmaceutical, electronics, or other regulated industries is highly preferred.
• Experience handling customer audits and regulatory compliance is an advantage.

Pay: RM3,000.00 - RM6,000.00 per month

Benefits:

• Opportunities for promotion
• Professional development

Work Location: In person