Quality System Specialist II

1. Evaluates customer complaints, including the coordination of documentation review, sample testing, and root cause analysis. Leads and/or facilitates the compliant investigation to reduce or eliminate causes of the complaints.

2. Analyzes complaint data and reports trends and triggers for significant complaint issues. Trends complaint data to identify significant changes and identifies chronic complaint categories.

3. Documents all activities related to complaint analysis, failure investigation, corrective action, preventive action, and effectiveness. Maintains customer complaint related files per policy/procedures.

4. Handles returned samples in a safe manner, taking all necessary precautions related to contaminated and ‘sharp’ products.

5. Audits corrective actions implemented to remedy complaints for effectiveness.

6. May participate in the site’s internal / external auditing function, developing audit reports and communicate them to auditees and the quality group.

7. Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate.

8. Manages the plant’s corrective/preventive action system as assigned to assure consistency and accuracy of specifications and procedures necessary to manufacture products of the highest quality and compliance to regulatory and company requirements. Performs the Site CAPA Leader responsibilities as defined in established procedures.

9. Manages the plant internal audit program as assigned to ensure compliance to Federal Regulations and International Standards as required.

10. Plans and performs intensive audits of the plant systems and procedures in accordance with established procedures. Coordinates plant audit teams to include training, scheduling, performing, and reporting of audit as necessary.

11. Conducts supplier audits to ensure compliance with QSR/ISO as directed by material requirements and company guidelines.