QUALITY ASSURANCE MANAGER
- Johor Bahru, Johor
- RM 6,000-9,000 per month
- Permanent
- Full-time
- Lead and manage the Quality Assurance system.
- Function as QMR and EMR, representing the company during audits and certification processes.
- Ensure compliance with ISO 9001, ISO 14001, and other applicable standards and regulations.
- Lead internal and external audits, including follow-ups with certification bodies.
- Develop and maintain Quality Inspection Standards and ensure consistent application across all production lines.
- Manage complaints, deviations, CAPA, non-conformances, and product replacements, including 8D reporting.
- Coordinate regular Management Review Meetings and quality performance monitoring (KPIs).
- Lead the Material Review Board (MRB), including actions on non-conforming materials and inventory control.
- Ensure effective document control, calibration schedules, validation activities, and risk management practices.
- Lead change control processes and provide technical support to operations on QA matters.
- Monitor product quality in the warehouse and approve handling instructions.
- Oversee and improve key QA processes such as SPC, MSA, FMEA, 7 QC tools.
- Drive Supplier Quality Management (SQM) including qualification, audits, and performance monitoring.
- Support quality aspects of new product development and introductions.
- Interface with regulatory authorities, customers, and external laboratories.
- Coordinate and implement sustainability and SDG-related initiatives.
- Train and develop QA team and build quality awareness across departments.
- Monitor and manage COQ (Cost of Quality).
- Draft and propose departmental budgets for EC approval.
- Degree in Engineering, Life Sciences, Medical Technology, or equivalent.
- 5–10 years of experience in Quality Assurance in a regulated manufacturing environment (preferably injection-moulding, healthcare, or educational models).
- Proven leadership and team management skills.
- Strong analytical, structured, and problem-solving capabilities.
- Excellent communication skills at all levels, fluent in English and Malay.
- Hands-on experience and deep knowledge of:
- Reliable, independent, and results-driven personality with high stress tolerance.
- Familiar with sustainability practices and regulatory trends (e.g., SDGs)