Job Description

• Continuous and versatile learning opportunities given
• Strong customer and stakeholder management in a regional exposure

About Our Client

Our client is a leading international medical technology company that creates medical devices and laboratory equipment to improve the standards of medical discovery, diagnostics and patient care delivery.

• Subject Matter expert for medical device complaint handling responsibilities from follow-ups to case processing and assessments for several countries in Asia Pacific and/or North America region.
• Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
• Initiate, track, follow-up and close Corrective and Preventive Actions.
• Monitor the Asia Pacific Regional Complaint Center Operational Metrics/Service Level Agreement performance to ensure operational level performance targets.
• Usage of Microsoft Excel with knowledge of formulas, statistical and modeling tools.
• Analyse information using problem-solving/root cause analysis.

The Successful Applicant

• Study background: BSc Degree preferably in scientific, technical or engineering discipline
• Minimum 2 years of Quality Assurance/Customer Complaint Specialist experience
• Quality System standards and regulations ISO 9000:2008, ISO 13485: 2016 or US FDA QSR (21 CFR 803 & 820) will be an advantage.
• Have fluent oral and written communication skills in English
• Demonstrated ability to work independently, manage deadlines, and handle multiple tasks efficiently
• Proficiency in statistical analysis and metrics reporting and associated tools and packages

What\'s on Offer

• Promising opportunity to advance in an international company
• Regional exposure to customers in Asia Pacific and/or North America region
• Comprehensive remuneration package designed to enhance financial well-being and health