Key Responsibilities

 Lead and maintain the Quality Management System (QMS) in accordance with ISO

13485:2016.

 Ensure compliance with Medical Device Rules (MDR 2017), CDSCO regulations,

and applicable statutory requirements.

 Develop, review, approve, and maintain SOPs, Work Instructions, Specifications,

Quality Manuals, and controlled documents.

 Manage incoming, in-process, and final product quality activities.

 Review and approve Batch Manufacturing Records (BMR), Device History Records

(DHR), and quality documentation.

 Lead investigations for deviations, non-conformities, customer complaints, and

implement effective CAPA.

 Conduct Root Cause Analysis using appropriate quality tools.

 Plan, conduct, and oversee internal audits and coordinate external, customer,

certification, and regulatory audits.

 Support regulatory inspections and ensure timely closure of audit observations.

 Monitor quality metrics, KPIs, and prepare quality performance reports for

Management Review Meetings.

 Implement Risk Management activities in accordance with ISO 14971.

 Ensure supplier qualification, vendor audits, and supplier performance monitoring.

 Ensure calibration, validation, qualification, and change control activities are

performed as per procedures.

 Coordinate employee training programs related to QMS, GMP, GDP, and regulatory

compliance.





 Support new product development and technology transfer activities from a quality

perspective.

 Promote continuous improvement initiatives to enhance product quality, process

efficiency, and regulatory compliance.

 Supervise and mentor the Quality Assurance team while fostering a strong quality

culture throughout the organization.

Required Skills

 Strong knowledge of ISO 13485:2016 Quality Management System.

 Thorough understanding of Medical Device Rules (MDR 2017) and CDSCO

regulations.

 Good knowledge of GMP, GDP, GLP, and Quality Risk Management.

 Experience in Internal Auditing and Audit Management.

 Robust knowledge of CAPA, Non-Conformance Management, Change Control, and

Deviation Investigation.

 Knowledge of ISO 14971 Risk Management.

 Excellent documentation, analytical, and problem-solving skills.

 Robust leadership, communication, and team management abilities.

 Proficiency in Microsoft Office applications.

Preferred Experience

 Experience in Medical Device or In-Vitro Diagnostic (IVD) manufacturing industry.

 Experience handling ISO 13485 certification audits.

 Experience interacting with CDSCO and regulatory authorities.

 Knowledge of Lean Manufacturing and Continuous Improvement methodologies is an

added advantage.

Pay: ₹600,000.00 - ₹800,000.00 per year

Work Location: In person

📌 QA Manager (India)
🏢 CURO Biosciences
📍 India