medical device

Sofomation Energy; India; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Sofomation Energy in India seeks an experienced medical device QMS auditor to conduct ISO 13485 audits, assess EU MDR, FDA 21 CFR 820 and MDSAP compliance, and review technical documentation and safety evidence. You will identify non-conformities and coordinate follow-up with internal teams.

Role requires leadership experience as a Lead Auditor for ISO 13485, sterilization expertise, and IRCA ISO 13485 & MDR assessor certifications are valued.

Qualifications

• Experience with sterilization processes for medical devices.
• Strong understanding of medical device quality and regulatory requirements.
• Experience as a lead auditor for ISO 13485 is preferred or required.
• IRCA-approved ISO 13485 & MDR assessor certifications are preferred.

Responsibilities

• Audit Medical Device QMS focusing on ISO 13485.
• Assess compliance with EU MDR, FDA 21 CFR 820 and MDSAP.
• Review technical documentation, validation and product safety evidence.
• Identify and report non-conformities and ensure follow-up.
• Prepare audit reports and coordinate with internal teams.
• Provide technical inputs to Sales and support customer engagements.
• Maintain auditor credentials and pursue professional certifications.

Skills

Sterilization of medical devices

Regulatory knowledge - MDQ/MDR/FDA

Lead Auditor ISO 13485

IRCA ISO 13485 & MDR Assessor certs

Job description

Role & responsibilities

• Conduct audits of Medical Device QMS, primarily ISO 13485.
• Assess compliance with EU MDR, FDA 21 CFR 820 and MDSAP requirements.
• Review technical documentation, validation and product safety evidence.
• Identify and report non-conformities and ensure effective follow-up.
• Prepare accurate, error-free audit reports and coordinate with internal teams.
• Provide technical inputs to Sales and support customer engagements.
• Maintain auditor credentials and pursue relevant professional certifications.

Key Requirement:

• Experience in Sterilization of medical devices/products is mandatory.
• Strong knowledge of Medical Device Quality & Regulatory requirements.
• IRCA-approved ISO 13485 & MDR Assessor certifications preferred/required as applicable.
• Experience as a Lead Auditor in ISO 13485.