QA Sr. Associate I, Complaints (Mandarin Speaker)
Alcon
Selangor – AGS, Unknown
Full-Time
$3
OfficeAssociate
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.
POSITION OVERVIEW:
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.
KEY RESPONSIBILITIES:
For Medical Device Safety Reporting:
Ensure required regulatory reports are complete and submitted on-time
Follow-up with internal functions and regulatory agencies to gather missing or required information to ensure compliance to requirements
Perform investigation for any late reporting, identify root-cause and implement required corrective actions
Participate in internal and external audits as a subject matter expert
Take ownership of the process and drive continuous improvements to enhance efficiency and effectiveness
Track required metrics for process oversight and escalate any issues as appropriate
Act as the subject matter expert on local regulations and requirements to support Alcon product portfolio
Exercise judgment within defined procedures and practices to determine appropriate action
Recommend improvements to current practices and procedures.
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.
Proactive identify compliance issues and compliance gaps, follow up and timely closure of observations in close cooperation with regional and global.
Ensure all processes, policies and procedures are clearly defined, fully documented
Ensure all processes comply with Alcon standards, policies, and applicable regulations
Responsible country(ies): China, Hong Kong, Taiwan
For Complaint Handling:
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.
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
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
Manage technical and AE complaint records for assigned area(s) using designated safety system(s)
Review potential complaint data received via safety system(s) and other methods, as required.
Work efficiently across applicable time zones to support timely complaint handling.
Performs all necessary reconciliation activities, including those related to customer oriented programs in accordance with procedures
Triage/ address calls from all sources regarding quality technical complaint, AE
Adheres to required metrics for all complaint handling responsibilities
Coordinate product return and shipping of samples to QA sites for further analysis
Close files in accordance with established guidelines and within required timelines
Maintain working knowledge of the following:
Company policies, departmental procedures, and applicable work instructions
Evolving local and international regulations, guidelines and applicable directives
Alcon products with assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials)
Eye anatomy, common diseases, ophthalmic procedures, terminology
Complaint management system, safety database and reporting tools
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.
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.
Responsible country(ies): APAC and SEA
Key Performance Indicators (KPI)
Quality and timely reporting of KPI and customer response
Complaint and/or AE intake and safety reporting compliance
No critical findings in audits or inspections
Customer feedback and satisfaction
HOW YOU CAN THRIVE AT ALCON:
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
Languages:
Fluent in both written and spoken English & Mandarin
Key Competencies/Behaviours:
Results Driven and Technically Competent.
Customer / Quality Focus
Empowerment / Accountability
Mutual Respect / Trust / Loyalty
Experience:
Minimum 2 year of experience in pharmaceutical and medical device industries
Proven ability in implementing quality and documentation systems.
Record of accomplishment of tracking complaints and safety reporting
Effective communicator
Experience working within multinational pharma companies or medical device company desirable
Comprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminology
HOW YOU CAN THRIVE AT ALCON:
Opportunity to work with a leading global medical device company
Collaborate with a diverse and talented team in a supportive work environment
Competitive compensation package and comprehensive benefits
Continuous learning and development opportunities
Alcon Careers
See your impact at alcon.com/careers
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If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.