Quality Management System (QMS): Maintain and update QMS procedures, manuals, and policies to align with standards like ISO 9001:2015, ISO 17025 (for labs), or IATF 16949 (for auto).
Audit Management: Lead internal audits and coordinate external audits, including vendor audits and regulatory inspections.
Documentation Control: Oversee document control, including Standard Operating Procedures (SOPs), Quality Manuals, and technical data.
CAPA & Non-Conformance: Initiate and manage Corrective and Preventive Actions (CAPA) for non-conformances, customer complaints, and audit findings.
Quality Metrics & Reporting: Monitor key performance indicators (KPIs), analyze quality data, and prepare performance reports for senior management.
Risk Management: Identify risks in processes and develop mitigation strategies.
Process Improvement: Drive continuous improvement projects (e.g., Lean Six Sigma, 5S) to improve quality and reduce costs.
Training: Train employees on quality standards, GMP, and new procedures.
