QUALITY ASSURANCE MANAGER
Job Title: Quality Assurance Manager
Principal Duties & Responsibilities
• 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.
Qualifications & Skills
• 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:
o ISO 9001 & ISO 14001
o SPC, MSA, FMEA, 7 QC tools
o Document control and CAPA processes
o Internal & external auditing (Lead Auditor preferred)
o Environmental and legal compliance
• Reliable, independent, and results-driven personality with high stress tolerance.
• Familiar with sustainability practices and regulatory trends (e.g., SDGs)
Kindly contact Ms Rachel at +6019-772 2619 for further details or send your resume to [rachel.gan@cityrecruit.com.my]
or
Kindly contact Mr Edwin +6012 692 5453 or send your resume to [crcs-my-recruitment@cityrecruit.com.my]
