Job highlights

- Competence in ISO 9001:2015 and ISO 13485:2016 audits with medical device industry knowledge
- Conduct and plan management system certification audits, evaluate QMS effectiveness, prepare audit reports, and ensure certification body compliance

Role & responsibilities: 1. Management System Certification Audits

•Conduct ISO 9001:2015 Quality Management System audits and/or ISO 13485:2016

Medical Device Quality Management System audits according to demonstrated competence and formal authorization.

•Perform Stage 1, Stage 2, surveillance, recertification and special audits, as applicable.

•Evaluate the implementation, conformity and effectiveness of clients' management systems.

•Review quality manuals, policies, procedures, records and relevant regulatory documentation.

•Identify nonconformities based on objective evidence.

•Prepare detailed audit reports, findings and conclusions.

2. Audit Planning and Execution

•Prepare and execute audit plans, checklists and audit programmes as assigned.

•Coordinate with audit team members and technical experts.

•Ensure timely submission of audit reports and associated records.

3. ISO 9001:2015 Audit Competence

•Demonstrate knowledge of ISO 9001:2015 requirements and quality management principles.

•Evaluate organizational processes, customer requirements, performance monitoring,





risk-based thinking and continual improvement.

•Possess relevant knowledge of industry-specific technical areas.

- Demonstrate competence in third-party QMS certification auditing. 4. ISO 13485:2016 Audit Competence

•Demonstrate knowledge of ISO 13485:2016 requirements applicable to medical device organizations.

•Evaluate medical device QMS documentation, design and development controls,

production controls, traceability and applicable regulatory requirements.

•Assess risk management interfaces, validation activities and supplier controls.

•Demonstrate relevant technical knowledge of medical device products, manufacturing processes and regulatory requirements.

•Possess medical device industry or certification audit experience appropriate to the proposed technical areas.

5. Certification Body Compliance

•Follow applicable requirements of ISO/IEC 17021-1:2015 and Assuretica's documented certification procedures.

•Maintain impartiality, objectivity, independence and confidentiality.

•Declare potential conflicts of interest before accepting audit assignments.

•Participate in competence evaluation, witnessed audits, training and ongoing performance monitoring.

•Maintain current records of qualifications, training and audit experience.

•Cooperate with applicable accreditation assessment activities.

📌 ISO Lead Auditor (New Delhi)
🏢 Assuretica Inspection u0026 Certification
📍 New Delhi