Senior Quality Assurance Analyst

Job Summary:

We are seeking a highly skilled and detail-oriented Senior Quality Assurance (QA) Specialist to join our team in a medical equipment manufacturing environment. The successful candidate will be responsible for ensuring compliance with applicable regulatory standards (FDA, ISO 13485, MDR, etc.), leading quality assurance activities across the product lifecycle, and supporting continuous improvement initiatives in both design and manufacturing processes.

Key Responsibilities:

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR regulations.
• Lead and participate in internal, supplier, and regulatory audits.
• Develop, implement, and maintain QA procedures, work instructions, and quality systems documentation.
• Support product development teams with design control activities, including risk management, verification, and validation.
• Lead CAPA (Corrective and Preventive Action) processes and conduct thorough root cause analyses.
• Oversee Non-Conformance (NC) investigations and support disposition activities.
• Coordinate supplier quality management, including supplier evaluations, audits, and performance monitoring.
• Participate in quality review boards (QRBs) and change control processes.
• Provide QA support during manufacturing transfer and process validation (IQ/OQ/PQ).
• Monitor and analyze quality metrics, prepare reports, and identify trends for continuous improvement.
• Train and mentor junior QA staff and cross-functional teams on quality policies and best practices.

Job Type: Full-time

Pay: ₹30,000.00 - ₹60,000.00 per month

Schedule:

• Day shift

Work Location: In person