Quality Specialist

Job description

**Wet Lab Quality Manager** **Experience:** 4–6Years **Role:** Quality Manager **Location** : Pune The current scope of work demands highly specialized expertise across multiple regulatory and quality standards governing medical laboratories, device validation, and testing environments. These include: **JOB Description** End-to-end implementation and maintenance of ISO/IEC 17025, ISO 15189, and ISO 13485 QMS frameworks Practical exposure to regulatory expectations (FDA, WHO, CLSI) in a medical laboratory setup **Proven experience in:** CAPA management and effectiveness checks Root Cause Analysis (5 Why, Fishbone) Risk management and deviation handling Change control systems Internal and external audit execution **Strong expertise in:** QMS documentation (SOPs, records, document control in audit-ready format) Data integrity principles (ALCOA+) Equipment qualification (IQ, OQ, PQ) Training and competency frameworks Laboratory-specific experience: Process and method validation Sample handling and traceability Calibration and uncertainty considerations Ability to establish and monitor: Quality metrics and KPIs Statistical trend analysis ISO/IEC 17025 – Testing & Calibration Laboratories ISO 15189 – Medical Laboratory Quality Management ISO 13485 – Medical Devices Quality Management Systems Regulatory frameworks (FDA, WHO, CLSI) NABL compliance and audit readiness Additionally, the work involves critical quality processes such as validation, CAPA, risk management, data integrity, and audit handling, which are essential to maintain compliance, accreditation, and client commitments.