19 Aug
|
WOW Softech
|
Bengaluru
19 Aug
WOW Softech
Bengaluru
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.
Solid 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.
📌 Medical Devices Auditor Non Active Devices Bengaluru
🏢 WOW Softech
📍 Bengaluru