Responsibilities:
- Configuration Management: Maintain accurate documentation of product configurations, revisions, and change control processes to ensure consistency and traceability.
- Quality Assurance & Control: Implement and enforce quality control measures across production processes to ensure compliance with internal and external quality standards.
- Process & Product Control: Monitor and analyze production processes to identify areas for improvement and implement corrective and preventive actions (CAPA).
- Manufacturing Support: Collaborate with production teams to troubleshoot quality issues and ensure products meet specifications before release.
- Compliance & Documentation: Ensure adherence to industry regulations (ISO, AS9100, FDA, etc.) and maintain quality documentation such as inspection records, deviation reports, and control plans.
- Audits & Inspections: Support internal and external audits, conduct process inspections, and implement necessary corrective actions.
- Continuous Improvement: Drive initiatives to enhance product quality and process efficiency through data analysis, root cause analysis, and best practices.
- Training & Support: Educate manufacturing personnel on quality standards, best practices, and process improvements.