
Executive, Complaint
2 weeks ago
This position is responsible for the customer complaint investigation process and provides quality oversight for the site to ensure that devices manufactured are compliant to ISO 13485, MDSAP, EU MDR, Alcon Standards and Policies, and regulatory requirements.
**Job Responsibilities**:
- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary.
- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
- Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
- Complete Complaint investigation report and maintenance of complaint master list, complaint samples, SOP revision and periodic review.
- Perform Site investigation (NCR, SAR, OOS, Complaints, etc.) and Site's WI/SOP/Gap Assessment/Impact Assessment.
- Participate as site representative in the Vision Care Complaints community at Global Corporate Platform.
- Lead/Host the site Customer Complaint Review Board (CCRB) meeting in the discussion on complaint investigations and evaluation of complaints trends.
- Support internal and external audits and is responsible for audit finding closure, as required.
- Work with cross-functional teams to resolve operational quality issues.
- Performs any other duties as assigned by Supervisor according to business needs.
**Education**:
- Diploma in Science / Engineering Fields
**Experience**:
- Minimum 3 years of working experience in a quality role
- Preferably with the medical device or pharmaceutical industry experience
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