Quality Assurance (QA) Complaint Handling Specialist (Korean Speaker)

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Job Overview
Responsible for day to day case management of quality technical and adverse event complaint records, including intake, follow up, triage, and system entry, involving Alcon devices and OTC products. Complaints handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.
 

Key Responsibilities:

• 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 incompliance with local and international regulations, guidelines and applicable directives.

• Receive initial complaint from any source (ECPs, patients, internal Alcon personnel) and assure all information/ data is accurately captured at pint of contact

• Maintain an understanding of information or date required to be collected of technical and AE complaints to assure compliance with regulations and directives

• Manage technical and adverse event complaint records for assigned areas using designated safety systems

• Review potential complaint data received via safety systems and other methods as required

• Perform intake/follow up/ data entry activities and attached corresponding source documents in a timely manner per requirements and directives.

• Perform all necessary reconciliation activities including for all customer oriented programs in accordance with procedures

• Triage/address calls from all sources for quality technical complaints, Adverse Events, request for refund, request for replacement product and requests for credit

• Adheres to require metrics for all complaint intake responsibilities

• Arrange for replacement , product return and shipping of samples to QA side for analysis

• Closes files according to establish guidelines to meet required timelines

• Maintain a working knowledge of company policies and procedures, departmental processes, and associated work instructions

• Evolving local and international regulations, guidelines and applicable directives

• Alcon products for assigned therapeutic areas and corresponding documentation (Product Insets, DFUs, Manuals, Promotional Materials)

• Informs management of potential safety issues, emerging trends and concerns

WHAT YOU’LL BRING TO ALCON:

Education:

• Tertiary qualification in ophthalmology or Science; or other healthcare discipline

Languages:

• Fluent in English and Korean (spoken and written).

Key Competencies/Behaviours:

• Technically Competent.

• Results Driven

• Customer / Quality Focus

• Empowerment / Accountability

• Mutual Respect / Trust / Loyalty

Experience:

• 1- 2 years of experience in pharmaceutical and medical device industries

• Proven ability in implementing quality and documentation systems.

• Record of accomplishment of tracking complaints

• Effective communicator

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.

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