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Quality System Specialist

Quality System Specialist

Careplix

3 - 5 years

2 - 5 Lacs

Kolkata

Posted:2 months ago| Platform:

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Skills Required

QMS Internal Audits Quality Improvement Document Control Management Review External Audits Risk Management Regulatory Compliance Calibration Management

Work Mode

Work from Office

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.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls.
Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms.Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up.Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications.Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness.Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.

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Quality System Specialist