QA Sr. Associate I, Complaints (Mandarin Speaker)

Selangor – Agssenior

OtherAssociate

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Quick Summary

Overview

At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed.

Technical Tools

OtherAssociate

At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.

Responsible for the day-to-day submission of regulatory reports (initial, follow‑up, and final) to local health authorities for medical devices. Works closely with the internal team and provides support as needed to ensure reports are complete, accurate, and submitted on time.

Responsible for the daily case management of quality, technical, and adverse event (AE) complaint records, including intake, acknowledgement, follow‑up, triage, system entry, and issuance of final responses for Alcon devices, pharmaceutical products, and over‑the‑counter products. Complaint handling responsibilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.

Responsibilities

~3 min read

For Medical Device Safety Reporting:

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Ensure required regulatory reports are complete and submitted on-time
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Follow-up with internal functions and regulatory agencies to gather missing or required information to ensure compliance to requirements
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Perform investigation for any late reporting, identify root-cause and implement required corrective actions
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Participate in internal and external audits as a subject matter expert
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Take ownership of the process and drive continuous improvements to enhance efficiency and effectiveness
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Track required metrics for process oversight and escalate any issues as appropriate
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Act as the subject matter expert on local regulations and requirements to support Alcon product portfolio
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Exercise judgment within defined procedures and practices to determine appropriate action
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Recommend improvements to current practices and procedures.
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Support and collaborate to ensure country inspection readiness (internal and/or external). Support for and ensure timely closure of audits, corrective plan, investigation related to regulatory report.
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Proactive identify compliance issues and compliance gaps, follow up and timely closure of observations in close cooperation with regional and global.
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Ensure all processes, policies and procedures are clearly defined, fully documented
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Ensure all processes comply with Alcon standards, policies, and applicable regulations
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Responsible country(ies): China, Hong Kong, Taiwan

For Complaint Handling:

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Ensure compliance of the regional/country complaint handling process for all Alcon products, including intake, follow up and triage for reports of quality/technical complaints and Adverse Events in compliance with local and international regulations, guidelines and applicable directives.
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Receive initial complaint from any source (e.g. NotifEye, ECP, HCP, patients, internal/ external Alcon representatives) and ensure all information and data are accurately captured at the point of contact
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Maintain a thorough understanding of the information and data required to be collected for both technical and adverse event (AE) complaints to assure compliance with regulations and directives
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Manage technical and AE complaint records for assigned area(s) using designated safety system(s)
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Review potential complaint data received via safety system(s) and other methods, as required.
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Work efficiently across applicable time zones to support timely complaint handling.
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Performs all necessary reconciliation activities, including those related to customer oriented programs in accordance with procedures
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Triage/ address calls from all sources regarding quality technical complaint, AE
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Adheres to required metrics for all complaint handling responsibilities
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Coordinate product return and shipping of samples to QA sites for further analysis
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Close files in accordance with established guidelines and within required timelines

Maintain working knowledge of the following:

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Company policies, departmental procedures, and applicable work instructions
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Evolving local and international regulations, guidelines and applicable directives
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Alcon products with assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials)
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Eye anatomy, common diseases, ophthalmic procedures, terminology
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Complaint management system, safety database and reporting tools
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Promptly inform management of potential safety issues, emerging trends and/or concerns. Ensure a business continuity plan is in place to guarantee uninterrupted availability of key vigilance processes and activities, or to mitigate the impact of an unwanted event through tested measures and procedures that enable efficient and effective business resumption and/ or recovery.
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Support, collaborate and ensure Country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to vigilance. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.
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Responsible country(ies): APAC and SEA

Key Performance Indicators (KPI)

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Quality and timely reporting of KPI and customer response
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Complaint and/or AE intake and safety reporting compliance
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No critical findings in audits or inspections
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Customer feedback and satisfaction

Education:

Minimum Required: Graduation in Science
Preferred Level: University Degree
Desirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline