QA Sr. Associate I – Complaints (Mandarin Speaker)

About the role

Alcon is seeking a Mandarin‑speaking Senior Quality Assurance Associate to manage regulatory reporting and complaint handling for its eye‑care products in the China, Hong Kong and Taiwan markets. The role ensures that all medical device safety reports and adverse event complaints are accurately recorded, investigated and submitted to the appropriate health authorities.

Key responsibilities

• Prepare and submit initial, follow‑up and final regulatory reports for medical devices to local health authorities.
• Manage daily case workflow for quality, technical and adverse event complaints, including intake, acknowledgement, triage, system entry and final response.
• Coordinate with internal functions and regulatory agencies to gather missing information and ensure on‑time compliance.
• Investigate late reporting incidents, identify root causes and implement corrective actions.
• Act as subject‑matter expert for local regulations (China, Hong Kong, Taiwan) and support audit readiness.
• Track process metrics, drive continuous improvement and escalate issues as needed.
• Support closure of audits, corrective plans and investigations related to regulatory reporting.

Required profile

• Fluent Mandarin (spoken and written) with strong English communication skills.
• Experience in regulatory reporting and complaint handling for medical devices or pharmaceutical products.
• Knowledge of local regulations and guidelines in China, Hong Kong and Taiwan.
• Ability to work independently, manage multiple cases and meet strict deadlines.

Required skills