18 Aug
|
WOW Softech
|
Bengaluru
18 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