Qa Ra Executive

Smartqr Technologies; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Smartqr Technologies seeks a Quality Assurance and Regulatory Specialist to maintain and implement the QMS per ISO 13485:2016. You will prepare QA/regulatory docs, including SOPs, Technical Files, DHF/DMR, IFU and labelling.

Join to support CAPA, NC, Change Control and risk management per ISO 14971, coordinate audits, and assist regulatory submissions for CDSCO, US FDA and EU MDR/IVDR while collaborating with R&D, Production and Clinical teams.

Responsibilities

• Maintain and implement the Quality Management System (QMS) as per ISO 13485:2016.
• Prepare and maintain QA and regulatory documentation, including SOPs, Technical Files, DHF/DMR, IFU and labelling.
• Support CAPA, Non-Conformity (NC), Change Control, and risk management activities as per ISO 14971.
• Coordinate internal/external audits and ensure timely closure of observations.
• Support regulatory submissions and compliance with CDSCO, US FDA, EU MDR/IVDR requirements.
• Coordinate with R&D, Production, Clinical, and other cross-functional teams for quality and regulatory activities.
• Maintain quality records and ensure document control and compliance.
• Support applicable IEC 62304 and IEC 62366 documentation.
• Monitor changes in applicable regulatory requirements and update relevant documentation.
• Travel to company locations/sites as required.

Job description

Role & responsibilities

Maintain and implement the Quality Management System (QMS) as per ISO 13485:2016.

Prepare and maintain QA and regulatory documentation, including SOPs, Technical Files, DHF/DMR, IFU and labelling.

Support CAPA, Non-Conformity (NC), Change Control, and risk management activities as per ISO 14971.

Coordinate internal/external audits and ensure timely closure of observations.

Support regulatory submissions and compliance with CDSCO, US FDA, EU MDR/IVDR requirements.

Coordinate with R&D, Production, Clinical, and other cross-functional teams for quality and regulatory activities.

Maintain quality records and ensure document control and compliance.

Support applicable IEC 62304 and IEC 62366 documentation.

Monitor changes in applicable regulatory requirements and update relevant documentation.

Travel to company locations/sites as required.