Job Description:

Position: QA/QC Specialist

Location: Umbergaon

Experience: 6 - 7 Years

Industries: Medical Devices

Responsibilities:

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Quality Management System (QMS)

Implement, maintain, and continuously improve the Quality Management System in accordance with CE, ISO 13485, ISO 9001, ISO 14001, ISO 45001, ISO/IEC 17025, and Indian MDR 2017 requirements.

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Ensure effective document control, change management, and compliance across all departments.

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Plan, conduct, and manage internal audits and coordinate external audits by CDSCO, NABL, BIS, AERB, CE, and Notified Bodies.

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Drive continuous improvement initiatives and ensure compliance with applicable standards and regulations.

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Regulatory Compliance & Documentation

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Ensure compliance with Indian Medical Device Regulations (MDR 2017), CDSCO requirements, labeling regulations, and applicable international standards.

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Prepare and maintain regulatory documentation for CE Marking, BIS Certification, AERB approvals, NABL Accreditation, and other statutory requirements.

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Support regulatory submissions and maintain readiness for inspections and audits at all times.

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Manage and update technical files, quality records, and compliance documentation

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Product Quality & Manufacturing Oversight

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Monitor product quality throughout the manufacturing lifecycle and ensure adherence to established quality standards.

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Review and approve validation and verification protocols, including IQ, OQ, and PQ activities.

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Collaborate with Production, R&D;, Regulatory Affairs, and other departments to ensure quality objectives are achieved.

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Lead quality review meetings and provide recommendations for process improvements.

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Non-Conformance Management & CAPA

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Investigate product non-conformances, deviations, and customer complaints.

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Conduct root cause analysis using appropriate quality tools and methodologies.

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Develop, implement, and monitor Corrective and Preventive Actions (CAPA).

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Track quality perfo

📌 QA/QC Specialist (Vapi)
🏢 Quality HR India
📍 Vapi