Senior Quality Assurance Executive – Hong Kong Market

About the role

The Senior Quality Assurance Executive will lead product complaint management, field corrective actions and non‑conformance activities for the Hong Kong market. The role ensures compliance with regulatory and company quality standards, supports rapid issue resolution, and drives continuous improvement through data analysis and root‑cause investigations.

Key responsibilities

• Assist in implementing and maintaining the Quality Management System (QMS) by aligning global standards with local processes.
• Manage product complaint handling, including data analysis, trend reporting and investigation to identify improvement opportunities.
• Assess and report adverse events to regulatory authorities according to applicable timelines.
• Coordinate field corrective actions (FCA), monitor progress and provide status updates to regional leads.
• Oversee product quarantine, disposition and release activities in collaboration with cross‑functional teams.
• Support non‑conformance (NC) and CAPA processes, including root‑cause analysis, corrective action implementation and effectiveness verification.
• Maintain quality documentation, filing systems and records for audit readiness.
• Participate in supplier qualification, internal and external audits, and other ad‑hoc QA projects.

Required profile

• Bachelor’s degree or diploma in science, quality management or a related field.
• Minimum 4 years of QA experience in medical devices, pharmaceuticals or a regulated healthcare environment.
• Strong analytical and problem‑solving abilities with a results‑oriented mindset.
• Excellent communication and interpersonal skills for cross‑functional collaboration.

Required skills

• Knowledge of ISO 9001 requirements.
• Hands‑on experience with complaint handling, field corrective actions, non‑conformance management and CAPA.
• Proficiency in root‑cause analysis methods such as 5 Whys, Fishbone (Ishikawa) diagrams and Failure Mode and Effects Analysis (FMEA).