Senior Manager - QA & RA

KOB Medical; Tiruppur; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

KOB Medical Textiles Pvt. Ltd., Tiruppur, seeks a Senior Manager - Quality Assurance & Regulatory Affairs to lead the quality and regulatory framework across the medical textile value chain.

You will drive QMS, regulatory compliance (MDR 2017), CAPA, risk management, supplier quality, and product development quality, partnering with manufacturing, development, and supply chain teams. Experience in the textile industry is a MUST.

Qualifications

• Experience in Textile Industry is MUST.

Responsibilities

• Lead the Quality Management System (QMS) implementation, maintenance and continual improvement.
• Ensure compliance with ISO 13485 and other regulatory requirements.
• Develop and maintain Quality Policies, 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.
• Ensure compliance with MDR 2017 and manage regulatory licenses and registrations.
• Coordinate ISO 13485 audits, internal and supplier audits, and regulatory inspections.
• Lead CAPA, risk management, change control and supplier quality initiatives.
• Oversee product development quality, validation programs, and manufacturing quality oversight.

Skills

Textile industry experience

Job description

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 full 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

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 new 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

<