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- Administers the complete customer complaint process, including complaint intake, initial assessment, investigation assignment, follow-up, documentation, and closure in accordance with established procedures and regulatory requirements.
- Coordinates complaint investigation activities performed by technicians and cross-functional team members.
- Reviews and closes no-sample/no-lot complaints in accordance with applicable procedures.
- Maintains complaint-related quality databases, records, dashboards, and key performance indicators (KPIs), ensuring data accuracy, completeness, and timely updates.
- Provides direct support during FDA, Corporate, TUV, and other applicable regulatory or quality system audits.




- Develops a detailed understanding of internal and external processes that may generate a Complaint and/or CAPA; verifies the accuracy of reported information and ensures that adequate objective evidence is available and properly documented.
- Coordinates the importation, receipt, tracking, and chain of custody of customer complaint samples submitted for investigation.
- Maintains and improves complaint-handling procedures, work instructions, templates, and internal documentation in compliance with corporate requirements, ISO 13485, FDA Quality System requirements, MDSAP, and other applicable regulations.
- Coordinates user training and manages technical and administrative activities associated with electronic complaint-handling and quality management systems.
- Supports customer complaint failure investigations, including unconfirmed failures, using structured root cause analysis and problem-solving tools such as Ishikawa diagrams, 5 Whys, affinity diagrams, fault tree analysis, DOE, and other applicable methodologies.
- Participates in CAPAs as

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