Key Responsibilities

1. Quality Management System (QMS)

QMS Leadership
· Lead the implementation, maintenance, and continual improvement of the Quality Management System.
· Ensure compliance with ISO 13485 and other applicable regulatory requirements.
· Develop and maintain Quality Policies, Standard Operating Procedures (SOPs), Work Instructions, and Quality Manuals.
· Monitor QMS performance through defined quality metrics and management reviews.
· Ensure document control and record retention systems remain effective.

Quality Performance Management
· Establish quality objectives aligned with organizational goals.
· Monitor process performance and product quality across all manufacturing operations.
· Drive quality improvement initiatives aimed at reducing defects, rework, customer complaints, and waste.
· Review quality trends and initiate preventive actions.

2. Regulatory Affairs & Compliance Management

Regulatory Compliance
· Ensure compliance with Medical Devices Rules (MDR) 2017.
· Maintain regulatory licenses, registrations, and certifications.




· Manage interactions with CDSCO and other regulatory authorities.
· Monitor changes in regulatory requirements and implement necessary actions.
· Support international regulatory submissions where applicable.

Product Registration and Documentation
· Review and approve regulatory documentation.
· Ensure accuracy and completeness of Technical Files.
· Maintain Device Master Records (DMR) and Device History Records (DHR).
· Support current product registrations and market authorization activities.

3. Audit & Inspection Management

Internal and External Audits
· Lead Internal Audit Programs.
· Act as Management Representative during external audits.
· Coordinate ISO 13485 audits, customer audits, supplier audits, and regulatory inspections.
· Ensure effective closure of audit observations and non-conformities.
· Maintain audit readiness across all departments.

Inspection Readiness
· Develop systems to achieve continua

📌 Head - QA & RA (Palladam)
🏢 KOB MEDICAL TEXTILES PRIVATE
📍 Palladam