Quality & Compliance Executive

Clinics On Cloud; Pune District; On-site; INR 400,000 - 600,000; Full time

Job summary

Clinics On Cloud is seeking a Quality Compliance professional to own quality and regulatory standards across its Health ATMs, Health Lounges, Box Clinics and Mobile Medical Units. You will build and maintain the QMS (ISO 13485 / ISO 9001), manage CDSCO medical device compliance, ensure DPDP Act and ABDM adherence, run audits, and lead CAPA on device and field issues.

Training on SOPs and safety will also be part of the role. Location is Pune, Maharashtra, with full-time employment.

Qualifications

• Strong documentation, analytical and communication skills.
• Willingness to travel to installation sites.

Responsibilities

• Manage regulatory compliance for our devices under the CDSCO Medical Device Rules, 2017, including registrations, licences and documentation
• Set and audit quality standards for kiosk installation, calibration, maintenance and field operations
• Train operations, field and clinical staff on SOPs, hygiene, safety and data-privacy practices
• Monitor quality KPIs and report regularly to leadership
• Prepare tender, client and government compliance documentation

Skills

Documentation skills

Analytical skills

Communication skills

Job description

Job Summary

Clinics On Cloud is looking for a Quality Compliance professional to own quality and regulatory standards across its Health ATMs, Health Lounges, Box Clinics and Mobile Medical Units. You'll build and maintain the QMS (ISO 13485 / ISO 9001), manage CDSCO medical device compliance, keep patient data handling in line with the DPDP Act and ABDM, run internal and external audits, and lead CAPA on device and field issues. You'll also prepare compliance documentation for government and corporate clients and train field and clinical teams on SOPs and safety.

Responsibilities

• Manage regulatory compliance for our devices under the CDSCO Medical Device Rules, 2017, including registrations, licences and documentation
• Set and audit quality standards for kiosk installation, calibration, maintenance and field operations
• Train operations, field and clinical staff on SOPs, hygiene, safety and data-privacy practices
• Monitor quality KPIs and report regularly to leadership
• Prepare tender, client and government compliance documentation

Requirements

• Strong documentation, analytical and communication skills
• Willingness to travel to installation sites

At a glance

• Team: Quality Regulatory Compliance
• Location: Pune - Maharashtra
• Type: Full time
• Experience: 0 - 2 Years