ISO LEAD AUDIT

Key Skills

ISO 13485 CERTIFICATION Walk in

Job Description

Roles & Responsibilities:

ü Act as Lead Auditor.

ü Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO - 2016

ü Assist clients with questions relevant to the audit and/or certification process.

ü Coordinate audit activity with team members.

ü Liaison with the client regarding audit activity.

ü Review client's quality management system documentation

ü Verify and Validate document evidence of compliance and non-compliance.

ü Prepare audit report.

ü Review audit results with the coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.

ü Assist with corrective action requirements resulting from assessments.

ü Participate in audit meetings.

Review audit reports and provide technical assistance to the Internal/External Team

ü Support management in areas of continuous improvement.

ü Plan ISO/CE/FDA audits by preparing and communicating audit plans.

ü Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance.

ü Communicate audit results through the preparation and publication of audit reports.

ü Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted.

ü Track implementation of corrective actions and verify actions for effectiveness.

ü Support management on tracking audit activities and administration of audit schedule.

ü Support external audits including interfacing with regulatory agencies and registrars if necessary.

ü Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (., QSR training, Quality Systems initiatives, etc.).
  • Experience

    1 - 3 Years

  • No. of Openings

    1

  • Education

    Any Bachelor Degree, B.Com, M.Com

  • Role

    ISO LEAD AUDIT

  • Industry Type

    Manufacturing / Production / Quality

  • Gender

    Male

  • Job Country

    India

  • Type of Job

    Full Time

  • Work Location Type

    Work from Office

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