Quality Management System (QMS)
- Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
- Develop, review, and update quality procedures, work instructions, forms, and templates.
- Ensure quality system processes are implemented and consistently followed throughout the organization.
- Support electronic Quality Management System (eQMS) administration and optimization.
Document Control
- Manage document control processes, including creation, revision, approval, release, and archiving of controlled documents.
- Monitor quality records for completeness, accuracy, and compliance.
CAPA Management
- Support root cause investigations using quality tools such as:
- 5 Whys
-Fishbone Diagrams
-Fault Tree Analysis
-Pareto Analysis
- Verify effectiveness of corrective actions and maintain CAPA records.
Nonconformance Management
- Support investigation and resolution of nonconforming materials, products, and processes.
- Analyze quality trends and recommend improvements.
Audit Management
-Internal audits
-Supplier audits
-External certification audits
-Regulatory inspections
- Prepare audit reports and ensure closure of audit findings.
- Support readiness activities for notified body and regulatory authority inspections.
Risk Management
- Participate in risk assessments and risk reviews.
Training and Compliance
- Ensure employees are trained and qualified on applicable procedures.
- Monitor training effectiveness and compliance metrics.
