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.
Strong knowledge of CAPA, Non-Conformance Management, Change Control, and
Deviation Investigation.
Knowledge of ISO 14971 Risk Management.
Excellent documentation, analytical, and problem-solving skills.
Strong 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
