Auditor- Non-Active Medical Devices

Job Description

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.