Quality Management System

QMS Quality Engineer

Maintain and enhance the Quality Management System (QMS) as per ISO 13485 and ISO 9001 requirements.

• Prepare, update, and control QMS documents including SOPs, Work Instructions, Forms, Manuals, and Records.
• Plan, execute, and report internal audits; track audit findings and ensure timely closure of corrective actions.
• Support external audits conducted by notified bodies, customers, and regulatory authorities.
• Lead CAPA processes including root cause analysis, corrective action planning, verification of effectiveness, and documentation.
• Coordinate and maintain Risk Management files in alignment with ISO 14971.
• Manage and monitor change control processes, ensuring evaluation, approval, and implementation of changes.
• Ensure timely reporting and documentation of deviations, nonconformities, SCARs, and improvement actions.
• Train employees on QMS procedures, compliance requirements, and documentation practices.
• Review device history records (DHR), batch records, and QMS compliance during manufacturing.
• Drive continuous improvement initiatives to strengthen compliance, efficiency, and documentation accuracy.
• Support process validation, equipment qualification, and regulatory submissions by providing QMS documentation.

Qualifications

• Strong understanding of ISO 13485, ISO 9001, and regulatory requirements applicable to manufacturing.
• Experience with QMS documentation, audits, CAPA, risk management, and change control.
• Knowledge of medical device regulations, MDR, and quality compliance systems.
• Ability to collaborate cross-functionally and effectively communicate QMS expectations.
• Strong analytical, documentation, and problem-solving skills.

Language Capabilities

English Professionally fluent

Education Requirements

Minimum: Degree in Engineering, Life Sciences, or related fields

Experience Requirements

• 27 years of experience in QMS, Quality Assurance, Compliance, or Regulatory roles.
• Hands-on experience with ISO 13485 implementation and maintaining QMS processes.
• Experience in documentation control, internal audits, and CAPA management.

Desirable Technical Requirements

• Certification in Internal Auditing (ISO 13485/9001) preferred.
• Knowledge of MDR, risk management (ISO 14971), and validation processes.
• Experience with QMS software tools like Windchill, MasterControl, or similar.
• Understanding of process validation, complaint handling, and supplier documentation.

Mobility & Travel Requirements

Primarily located at the Faridabad facility with occasional travel for audits, supplier visits, or regulatory meetings as required.

Equal Opportunity Statement

The ESAB Group Inc. is an equal opportunity employer. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law.

Preferred candidate profile