Responsible for maintaining and enhancing the Quality Management System (QMS), ensuring regulatory compliance, and driving product/process quality across all operations.
Key Responsibilities:
- QMS Management: Maintain, audit, and update QMS documentation (SOPs, Work Instructions, Quality Manuals) in accordance with industry standards (e.g., ISO 9001, ISO 13485, GMP).
- Compliance & Audits: Lead internal audits, coordinate external/regulatory audits, and track CAPA (Corrective and Preventive Actions) to resolution.
- Process & Product QA: Monitor production/operational workflows, conduct root-cause analysis (RCA) for quality deviations, and drive continuous improvement initiatives.
- Risk & Vendor Quality: Conduct risk assessments, evaluate vendor quality compliance, and perform incoming/in-process quality checks.
- Training & Reporting: Train staff on quality standards and compliance protocols; report key quality metrics (KPIs) to senior management.
Requirements:
- Experience: 3–5 years in QA, QMS handling, and regulatory compliance.