Key Responsibilities
- Complaint Management & Customer Support
- Manage and resolve internal quality complaints from cross-functional stakeholders.
- Handle external customer complaints professionally, ensuring timely investigation, root-cause analysis, and effective corrective actions.
- Oversee the return and disposition process for defective materials
Data Analysis & Reporting
- Analyze complaint data, determine appropriate sample sizes, and evaluate acceptable error margins.
- Monitor and review quarterly complaint trends to identify risks and improvement opportunities.
- Prepare clear, comprehensive quality reports with actionable recommendations for management review.
Quality System & Continuous Improvement
- Provide technical quality support and guidance to customers and internal teams.
- Utilize quality tools and methodologies to support investigations, corrective actions, and process improvements.
- Ensure compliance with ISO 13485 and ISO 9001 requirements and support audits when required.
Requirements
- Preferably Degree in Engineering, Quality Management or related field.
- Must have proven experience in Quality Assurance within manufacturing, medical device, or regulated industries.
- Strong working knowledge of ISO 13485 and ISO 9001 quality management systems.
- Experience in complaint handling, CAPA, root-cause analysis, and quality reporting.
- Proficiency in quality tools (e.g., 8D, Fishbone, 5 Why, FMEA, statistical analysis).
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently and collaborate with cross-functional teams.
