Quality System Specialist

3 - 5 years

2 - 5 Lacs

Posted:13 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.Regulatory Compliance: Apply your strong knowledge of FDA QSR, ISO 13485, and EU MDR to ensure all activities meet regulatory norms.
QMS Management: Manage essential Quality Management System (QMS) documentation, including Design History Files (DHFs) and Corrective and Preventive Actions (CAPAs).Audits & Reviews: Support internal and external audits, manage supplier qualifications, and oversee training and calibration programs.Cross-functional Support: Provide critical quality support for product development, drive quality improvements, and ensure ongoing regulatory compliance.

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