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, drives timely issue resolution and supports continuous improvement across the region.

Key responsibilities

• Assist in implementing and maintaining the Quality Management System (QMS) in line with global standards.
• Manage product complaint handling, perform data analysis, trend reporting and investigations to identify improvement opportunities.
• Assess and report adverse events to regulatory authorities according to applicable timelines.
• Coordinate and monitor Field Corrective Actions (FCA), providing status updates to regional leads.
• Collaborate with cross‑functional teams on product quarantine, disposition and release activities.
• Support Non‑Conformance (NC) and CAPA processes, including root‑cause analysis, corrective action implementation and effectiveness verification.
• Maintain quality documentation, filing systems and audit‑ready records.
• Assist supplier qualification and evaluation to ensure compliance with quality standards.
• Participate in internal, external and corporate audit activities.
• Perform ad‑hoc QA duties and projects as assigned.

Required profile

• Bachelor’s degree or Diploma in science, quality management or a related field.
• Minimum 4 years of Quality Assurance experience in medical devices, pharmaceuticals or healthcare.
• Knowledge of ISO 9001 and experience with internal or external audits.
• Hands‑on experience in complaint handling, FCA, NC management and CAPA.
• Strong analytical and problem‑solving abilities with proven root‑cause analysis expertise.
• Excellent communication and interpersonal skills.
• Highly organized, results‑oriented and able to manage multiple priorities in a fast‑paced environment.

Required skills

• ISO 9001
• 5 Whys
• Fishbone (Ishikawa) Diagrams
• Failure Mode and Effects Analysis (FMEA)
• Root‑cause analysis
• Data analysis
• CAPA processes
• Complaint handling