ISO Lead Auditor

Assuretica Inspection & Certification Pvt. Ltd.; New Delhi; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Assuretica Inspection & Certification Pvt. Ltd. is seeking qualified auditors to conduct ISO 9001:2015 and ISO 13485:2016 audits, including Stage 1/Stage 2, surveillance and recertification.

You will evaluate client QMS implementation, review documentation, and prepare detailed audit reports. Responsibilities include planning audits, coordinating with team members and experts, and ensuring timely submission of records.

Responsibilities

• Conduct ISO 9001:2015 Quality Management System audits and ISO 13485:2016 Medical Device QMS audits.
• 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.
• 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.
• Demonstrate knowledge of ISO9001:2015 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.
• Demonstrate knowledge of ISO13485:2016 requirements applicable to medical device organizations.
• Evaluate medical device QMS documentation, design and development controls, production controls, traceability and 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.
• Follow applicable requirements of ISO/IEC17021-1:2015 and Assuretica's documented certification procedures.
• Maintain impartiality, objectivity, independence and confidentiality.
• Declare potential conflicts of interest before accepting an 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.

Job description

Role & responsibilities:

1.ManagementSystemCertificationAudits

• ConductISO9001:2015QualityManagementSystemauditsand/orISO13485:2016
  MedicalDeviceQualityManagementSystemauditsaccordingtodemonstrated
  competenceandformalauthorization.
• PerformStage1,Stage2,surveillance,recertificationandspecialaudits,as
  applicable.
• Evaluatetheimplementation,conformityandeffectivenessofclients'management
  systems.
• Reviewqualitymanuals,policies,procedures,recordsandrelevantregulatory
  documentation.
• Identifynonconformitiesbasedonobjectiveevidence.
• Preparedetailedauditreports,findingsandconclusions.

2.AuditPlanningandExecution

• Prepareandexecuteauditplans,checklistsandauditprogrammesasassigned.
• Coordinatewithauditteammembersandtechnicalexperts.
• Ensuretimelysubmissionofauditreportsandassociatedrecords.

3.ISO9001:2015AuditCompetence

• DemonstrateknowledgeofISO9001:2015requirementsandqualitymanagement
  principles.
• Evaluateorganizationalprocesses,customerrequirements,performancemonitoring,
  risk-basedthinkingandcontinualimprovement.
• Possessrelevantknowledgeofindustry-specifictechnicalareas.
• Demonstratecompetenceinthird-partyQMScertificationauditing.

4.ISO13485:2016AuditCompetence

• DemonstrateknowledgeofISO13485:2016requirementsapplicabletomedical
  deviceorganizations.
• EvaluatemedicaldeviceQMSdocumentation,designanddevelopmentcontrols,
  productioncontrols,traceabilityandapplicableregulatoryrequirements.
• Assessriskmanagementinterfaces,validationactivitiesandsuppliercontrols.
• Demonstraterelevanttechnicalknowledgeofmedicaldeviceproducts,manufacturing
  processesandregulatoryrequirements.
• Possessmedicaldeviceindustryorcertificationauditexperienceappropriatetothe
  proposedtechnicalareas.

5.CertificationBodyCompliance

• FollowapplicablerequirementsofISO/IEC17021-1:2015andAssuretica's
  documentedcertificationprocedures.
• Maintainimpartiality,objectivity,independenceandconfidentiality.
• Declarepotentialconflictsofinterestbeforeacceptingauditassignments.
• Participateincompetenceevaluation,witnessedaudits,trainingandongoing
  performancemonitoring.
• Maintaincurrentrecordsofqualifications,trainingandauditexperience.
• Cooperatewithapplicableaccreditationassessmentactivities.