Quality Assurance Executive - QMS

OptraSCAN, Inc.; Pune District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

OptraSCAN, Inc. in Pune is seeking a Quality Compliance Specialist to support QMS integrity across digital pathology systems and SaMD portfolio. You will maintain documentation, coordinate audits, perform QC checks, and ensure compliance with ISO 13485 and related standards.

The ideal candidate has 3-5 years of experience in QA/QMS, possesses an Internal Auditor certification or ISO 14971 training, and is proficient in Microsoft Office. Immediate start preferred.

Qualifications

• Experience in QA/QMS for medical devices or digital health products.
• Knowledge of ISO 13485 and CAPA tracking.
• Internal Auditor certification is preferred.
• ISO 14971 training is beneficial.
• Proficient with Microsoft Office.

Skills

QMS principles

Internal Auditor certification

CAPA tracking

ISO 14971 training

Tools

Microsoft Office

Job description

Job Summary

Support QMS integrity across digital pathology systems and SaMD portfolio. Maintain documentation, coordinate audits, perform QC checks, and ensure compliance with ISO 13485 and related standards.

Key Skills

• QMS principles, ISO 13485
• Internal Auditor certification
• CAPA tracking, document control
• ISO 14971 training
• Microsoft Office proficiency

Details

Location: Pune

Experience: 3-5 years

Notice: Immediate - 15 days

Department: Quality