Overview

QA Operations Manager to lead quality management and governance across site operations, ensuring full compliance with regulatory and quality system requirements (e.g., ISO13485, MDSAP, FDA, EU MDR). The role oversees packaging quality processes, product release, and laboratory testing, while building a competent and compliant team. It also supports manufacturing sites in resolving quality issues through root cause analysis and preventive actions and ensures effective quality control plans are in place to consistently meet product, customer, and regulatory standards.

Responsibilities

• Manage routine QA activities within operation areas for all sites (Kuala Ketil / Kulim / Kulim Hi-Tech).
• Responsible for testing and final release of products.
• Support and assist manufacturing in quality and regulatory requirements across all manufacturing sites (Kuala Ketil / Kulim / Kulim Hi-Tech).
• Production & Process Controls – revi...