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Auditor- Non-Active Medical Devices

2 months ago

Bengaluru, India TÜV SÜD Full time

Job Location: Pan India

Key Responsibilities

  • Supports the audit together with the lead auditor as QMS Auditor and Technology Auditor as applicable.
  • Performs assigned site audits / onsite audits as Lead Auditor and audit team leader.
  • Performs the audit together with the lead auditor and contributes to the report regarding MDS 7006/1005 and IVS 1005 on aspects other than validation as Sterilization Basic Auditor.
  • Carrt out Project Handler / CARE (Project Management) Task as assigned.
  • Performed Technical Documentation Assessment for authorized Codes.
  • Contributes to technical documentation assessments and to conformity assessment procedures. Signs technical reports or provides an opinion in the field of his/her authorization that contributes to the conformity assessment.


Additional Knowledge / Skills (If any)

  • Knowledge in Medical Device Quality Mangement System
  • Knowledge in EU and International Regulations on Medical Devices


Education

  • Graduation in biology or microbiology, chemistry or biochemistry, mechanical engineering or bioengineering, human physiology, medicine, pharmacy.


Certification or Training (If any required)

  • Not Mandatory but preferred QMS LA on ISO 13485 or ISO 9001
  • Awareness program on EU / International Regulatory frame works on Medical Devices
  • other trainings on risk management, including risk analysis, process validation, sterilization and related processes.


Competencies

  • Fundamental Competencies (Mandatory)
  • minimum of four years of full-time work experience in the field of medical devices or related sectors (e.g., medical device industry,
  • healthcare, medical device audit or research in medical devices)
  • Two years of above four years work experience in Design, Manufacturing, Application of the medical devices.