Qa jobs in Malaysia

Kuala Lumpur, Malaysia | Posted on 12/02/2025

Lead and oversee the company’s quality strategy across all manufacturing sites, ensuring consistent standards and alignment with corporate objectives. Partner with senior leadership to establish long-term quality initiatives, monitor key performance metrics, and ensure compliance with global regulatory requirements. Maintain a robust Quality Management System (QMS), drive continuous improvement efforts, manage enterprise-level quality risks, and foster a strong, organisation-wide quality culture.

Provide strategic leadership for Quality Assurance across all plant and central functions.

Develop and implement quality strategies and long-term improvement plans that align with business objectives and regulatory requirements.

Ensure effective implementation, maintenance, and enhancement of QMS frameworks (ISO 13485, FDA QSR, MDR, MDSAP) across the organisation.

Monitor QA performance across plants and central teams using KPIs, benchmarks, and structured performance reviews.

Drive harmonisation of QA systems, including CAPA, change control, complaints handling, audits, laboratory testing, calibration, and validation processes.

Ensure corrective and preventive actions are executed consistently and sustained throughout all plants.

Assess quality risks and enforce mitigation plans across operational areas.

Lead preparation and readiness for regulatory inspections and major customer audits.

Collaborate closely with leadership to integrate quality objectives into business strategy.

Lead escalation management for critical quality issues, regulatory findings, and supplier rejections, ensuring effective resolution.

Facilitate cross-functional root cause analysis and implementation of long-term preventive actions for systemic issues.

Manage QA budgets, resources, and headcount to support optimal operational execution.

Oversee quality aspects in NPI/NPD to ensure compliance with regulatory and system requirements.

Lead performance evaluations, development initiatives, and succession planning for QA teams.

Perform additional duties as required.

Lead, mentor, and develop QA leaders to ensure capability, alignment, and strong performance.

Promote knowledge sharing and cultivate a proactive, quality-driven culture.

Drive talent development and succession planning across all levels of the QA function.

Build strong internal partnerships with Operations, R&D, Sales, Procurement, and Supply Chain teams.

Serve as the primary liaison with regulators, customers, and industry bodies on quality-related matters.

Champion change management and continuous improvement initiatives.

Represent the QA function in leadership forums and strategic discussions.

Oversee performance appraisals, career development, and succession planning for direct reports and broader QA teams.

Bachelor’s or Master’s Degree in Engineering, Science, or a related field.

Minimum of 15 years of experience in manufacturing, including at least 8 years in managerial roles; experience in medical devices or other regulated industries is preferred.

Demonstrated leadership in QMS, regulatory compliance, and customer-facing quality functions.

Proven experience overseeing multi-site QA operations and leading regulatory inspections.

Strong understanding of GMP and manufacturing technologies.

In-depth knowledge of QMS standards (FDA QSR 21 CFR 820, ISO 13485, ISO 14971, ISO 2859, ISO 9001).

Proficient in CAPA, root cause analysis, and quality auditing.

Familiar with Lean methodologies and operational excellence practices.

Strategic thinker with strong analytical, problem-solving, and project management capabilities.

Excellent communication, negotiation, leadership, and people development skills.

Skilled in complaint analysis and driving systemic quality improvements.

ISO 13485 Lead Auditor certification or equivalent is preferred.