To ensure that all products are manufactured and released in compliance with regulatory, statutory, and quality requirements, maintaining a robust Quality Management System (QMS).
Key Responsibilities
Quality Management System (QMS)
- Establish and maintain QMS as per:
- ISO 13485
- EU MDR (2017/745)
- FDA (21 CFR Part 820 / QSR)
QA Oversight
- Approve:
- BMR/BPR
- SOPs
- Change controls
- Ensure document control and traceability
QC Management
- Oversee:
- Incoming inspection
- In-process inspection
- Final inspection
CAPA & Risk Management
- Lead:
- Deviation handling
- Root Cause Analysis (RCA)
- CAPA implementation
- Implement ISO 14971 Risk Management
Validation & Qualification
- Oversee:
- Process validation
- Equipment qualification (IQ/OQ/PQ)
- Sterilization validation
Audit Management
- Handle:
- Internal audits
- External audits (Notified Body / FDA / Customers)
- Ensure audit readiness
Regulatory Compliance
- Ensure compliance with:
- CE marking requirements
- Technical documentation
- Clinical evaluation
Pay: ₹60,000.00 - ₹65,000.00 per year
Work Location: In person
