QA/QC Specialist
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 performance indicators and present reports to management.
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Supplier Quality Management
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Evaluate, qualify, and audit suppliers to ensure compliance with quality requirements.
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Oversee incoming material inspections and supplier performance monitoring.
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Ensure supplier quality agreements and documentation are maintained effectively.
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6. Training & Team Development
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Develop and conduct training programs on QMS, Good Documentation Practices (GDP), regulatory compliance, and quality standards.
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Mentor and guide QA/QC team members to enhance competency and performance.
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Foster a culture of quality awareness and continuous improvement throughout the organization.
Required Skills
- SO 13485
- ISO 9001
- ISO 14001
- ISO 45001
- ISO/IEC 17025
- Indian MDR 2017
- BIS Certification
- AERB Requirements
- NABL Accreditation
- Risk Management (ISO 14971)
- DMF & PMF Documentation
- Validation & Verification Processes
- CAPA and Root Cause Analys
Required Qualification: - B.E/B.Tech - Engineering
Salary :- Upto 6.00 LPA
If you are interested for this opening please send updated resume on same mail with following details.
Total No. of Years Experience :-
Current CTC :-
Expected CTC :-
Notice Period :-
Company Profile
A leading manufacturer in the healthcare and --- device industry, specializing in high-quality disposable --- products. The product portfolio includes IV Cannulas, Infusion Sets, Blood Transfusion Sets, Syringes, Needles, Catheters, Extension Lines, Three-Way Stop Cocks, and other critical hospital consumables, delivering reliable solutions that meet stringent quality and safety standards.
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