Medical Devices Auditor | Non Active Devices

WOW Softech; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

WOW Softech in Bengaluru is seeking an experienced audit professional to conduct ISO 13485, EU MDR and MDSAP audits. You will assess QMS, risk management and CAPA processes, identify non-conformities, and prepare formal audit reports for clients.

The ideal candidate has 5+ years in the medical device industry and strong knowledge of ISO 13485, EU MDR, MDSAP, ISO 14971 and CAPA. Lead Auditor certification is preferred and candidates from manufacturers, notified bodies, or certification bodies are

Qualifications

• 5+ years in the Medical Device industry.
• Experience in QA, QMS, Regulatory Affairs, Compliance or Auditing.
• Strong knowledge of ISO 13485, EU MDR, MDSAP, ISO 14971, CAPA and Risk Management.
• ISO 13485 Lead Auditor certification preferred.

Responsibilities

• Conduct audits against ISO 13485, EU MDR, MDSAP and applicable regulatory requirements.
• Assess QMS, risk management, CAPA, manufacturing processes and compliance activities.
• Identify non-conformities and review corrective actions.
• Prepare audit reports and communicate findings to clients.
• Support certification and surveillance audit activities.
• Stay updated with medical device regulations and industry standards.

Skills

Quality Assurance

Quality Management

Regulatory Affairs

Compliance

Auditing

Tools

Lead Auditor Certification

MDSAP

Job description

Role & Responsibilities

• Conduct audits against ISO 13485, EU MDR, MDSAP, and applicable regulatory requirements.
• Assess Quality Management Systems (QMS), risk management, CAPA, manufacturing processes, and compliance activities.
• Identify non-conformities and review corrective actions.
• Prepare audit reports and communicate findings to clients.
• Support certification and surveillance audit activities.
• Stay updated with medical device regulations and industry standards.

Preferred candidate profile

• 5+ years of experience in the Medical Device industry.
• Experience in Quality Assurance, Quality Management, Regulatory Affairs, Compliance, or Auditing.
• Strong knowledge of ISO 13485, EU MDR, MDSAP, ISO 14971, CAPA, and Risk Management.
• ISO 13485 Lead Auditor certification is preferred.
• Candidates from Medical Device Manufacturers, Notified Bodies, or Certification Bodies are encouraged to apply.