Experience in Textile Industry is MUST....

Position Title - Senior Manager - Quality Assurance & Regulatory Affairs

Department - Quality Assurance & Regulatory Affairs

Location - KOB Medical Textiles Pvt. Ltd., Tiruppur

Reports To - General Manager / Director Operations

Grade - Senior Management

Direct Reports - QA Managers, Quality Engineers, Regulatory Executives, Lab Personnel, Quality Inspectors

Employment Type - Full Time

Position Purpose

To lead and continuously strengthen KOB Medical Textiles' quality and regulatory framework by ensuring that all medical textile products, manufacturing processes, supplier systems, and product development activities comply with applicable quality and regulatory requirements while meeting customer expectations for safety, performance, and reliability.

The position is responsible for driving quality excellence across the complete medical textile value chain, from raw material qualification and textile manufacturing processes to finished product release, customer satisfaction, and regulatory compliance. The incumbent will provide leadership in Quality Assurance, Regulatory Affairs, Risk Management, Product Development Quality, Supplier Quality, and Continuous Improvement initiatives, ensuring that KOB Medical Textiles maintains its position as a trusted manufacturer of world-class medical textile solutions.

The role shall act as the custodian of the Quality Management System and regulatory compliance framework while partnering with Manufacturing, Product Development, Supply Chain, and Commercial teams to deliver sustainable business growth through superior product quality, operational excellence, and regulatory confidence.

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 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:
- 5 Why Analysis
- Fishbone Analysis
- 8D Methodology
- 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:
- Process Validation
- Equipment Qualification
- Packaging Validation
- Cleaning Validation (if applicable)
- 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:
- Quality Systems
- Regulatory Compliance
- Risk Management
- GMP Practices
- Product Specifications
- 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 Engineering, Quality Management, Regulatory Affairs, or Business Administration.

Experience

Essential

- 12-15 years of experience in:
- Quality Assurance of a reputed Textile Industry. Medical textile industry is desirable.

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.

📌 Senior Manager - QA & RA (Palladam)
🏢 KOB Medical
📍 Palladam