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 recent 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 continual inspection readiness.

· Conduct compliance assessments and gap analyses.

· Monitor effectiveness of corrective actions.

4. CAPA, Risk Management & Change Control

Corrective and Preventive Action (CAPA)

· Lead investigations related to complaints, non-conformities, deviations, and audit findings.

· Ensure robust root cause investigations using:

o 5 Why Analysis o Fishbone Analysis o 8D Methodology o Fault Tree Analysis

· Verify effectiveness of implemented CAPAs.

Risk Management

· Facilitate risk assessments using FMEA and other risk management tools.

· Ensure identified risks are adequately controlled and monitored.

· Review risk management documentation periodically.

Change Control





· Chair Change Control Review meetings.

· Review quality and regulatory impact of proposed changes.

· Ensure validation requirements are adequately addressed.

· Approve implementation and closure of changes.

5. Supplier Quality Management

Supplier Qualification

· Establish supplier qualification and approval processes.

· Review supplier capability assessments and audit reports.

· Approve critical suppliers.

Supplier Performance Monitoring

· Develop supplier scorecards and performance metrics.

· Lead supplier development initiatives.

· Monitor supplier corrective actions and effectiveness.

Incoming Quality Assurance

· Ensure effective raw material inspection programs.

· Review supplier-related quality trends and complaints.

· Drive supplier quality improvements.

6. Product Development & Validation Support

New Product Development

· Participate in product design and development reviews.

· Ensure quality requirements are integrated into product development activities.

· Support design verification and validation programs.

Validation Programs

· Lead:

o Process Validation o Equipment Qualification o Packaging Validation o Cleaning Validation (if applicable)

o Software Validation (where required)

· Ensure validation activities meet regulatory and quality requirements.

7. Medical Textile Process Quality

Manufacturing Quality Oversight

Provide quality leadership across

· Warping

· Weaving

· Knitting

· Lamination

· Coating

· Confectioning

· Packaging

Process Improvement

· Monitor process capability and quality performance.

· Implement Statistical Process Control (SPC).

· Reduce process variation and improve product consistency.

· Lead root cause investigations related to textile and medical textile manufacturing defects.

8. Customer Quality & Complaint Management

· Review customer complaint investigations.

· Ensure timely closure of complaints.

· Analyse complaint trends and implement preventive actions.

· Participate in customer quality reviews and technical discussions.

· Support customer audits and business development initiatives.

9. Leadership & Team Development

Team Management

· Lead and manage QA & RA teams.

· Establish departmental objectives and KPIs.

· Monitor productivity and employee performance.

Talent Development





· Develop succession plans within the department.

· Provide coaching and mentoring to team members.

· Conduct training programs on:

o Quality Systems o Regulatory Compliance o Risk Management o Product Specifications o Audit Requirements

10. Strategic & Cross-Functional Leadership

· Partner with Manufacturing, Supply Chain, Purchasing, Product Development, Engineering, and Commercial teams.

· Support business expansion projects and technology transfers.

· Participate in management reviews and strategic planning activities.

· Drive quality culture initiatives throughout the organization.

· Lead continuous improvement programs using Lean and Six Sigma principles.

Educational Qualification

Essential

- Bachelor's Degree in:
- Textile Technology
- Textile Engineering

Preferred

- Master's Degree in Textile Engineering,

Experience

Essential

- 20+ years of experience in:
- Quality Assurance of a reputed Technical textile industry.

Mandatory Experience

- ISO 13485 implementation and maintenance.
- Regulatory compliance management.
- Internal and external audit management.
- CAPA and Risk Management.
- Team management and leadership.

Technical Competencies

- ISO 13485
- MDR 2017
- CDSCO Regulations
- BIS Standards
- Quality Management Systems
- CAPA Management
- Root Cause Analysis
- Risk Management
- FMEA
- SPC
- Product Validation
- Supplier Quality Management
- Internal Auditing
- Technical Documentation
- Medical Textile Manufacturing Processes
- Change Control Systems
- Quality Metrics and Data Analytics

Behavioural Competencies

- Strategic Thinking
- Leadership & Team Development
- Decision Making
- Problem Solving
- Customer Focus
- Stakeholder Management
- Communication Skills
- Influencing Ability
- Conflict Resolution
- Continuous Improvement Mindset
- Results Orientation
- Accountability

Key Performance Indicators (KPIs)

- QMS Compliance Score
- Audit Compliance Score
- Regulatory Readiness Score
- CAPA Effectiveness Index
- Customer Complaint Closure Rate
- Supplier Quality Performance
- Change Control Compliance
- Product Non-Conformance Rate
- Scrap & Rejection Reduction
- Cost of Poor Quality (COPQ)
- Product Trial Success Rate
- Training Effectiveness Score
- Internal Audit Closure Rate
- On-Time Regulatory Submissions
- Customer Satisfaction Index

Authority Matrix The incumbent is authorized to:

- Approve Quality Management System documents.
- Approve CAPA closures.
- Approve quality-related change controls.
- Recommend product disposition decisions.
- Escalate compliance and regulatory risks.
- Stop production or product release in case of quality or regulatory concerns.
- Approve supplier qualification recommendations within delegated authority.

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