QA Lead

Position Summary:

We are seeking a proactive and detail-oriented Quality Assurance Lead to support and execute key QA activities for in-vitro diagnostic (IVD) medical devices. The QA Lead will work closely with internal teams including Manufacturing, Regulatory Affairs, QC and Supply Chain, to ensure quality standards are maintained throughout the product lifecycle. This role reports to the Manager – QA and involves hands-on execution of quality processes, cross-functional coordination, and compliance with applicable standards and regulations such as ISO 13485, MDR-2017 (India) and IVDR - (EU) 2017/746

Key Responsibilities:

• Assist in the execution, maintenance, and improvement of the Quality Management System (QMS) in accordance with ISO 13485, MDR-2017 and IVDR requirements.
• Coordinate with cross-functional teams to ensure QA involvement in all relevant processes including manufacturing, and post-market activities.
• Support internal and external audits, including preparation, documentation, and execution of follow-up actions and CAPAs.
• Handle documentation control, including SOPs, work instructions, forms, and records, ensuring timely updates and compliance with quality standards.
• Conduct routine quality checks, inspections, and in-process audits as needed.
• Assist in the investigation and resolution of non-conformances, deviations, and customer complaints; support root cause analysis and CAPA implementation.
• Support supplier qualification and monitoring activities by coordinating assessments and maintaining related records.

Qualifications:

• Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field.
• 4–6 years of relevant experience in Quality Assurance within the medical device or IVD industry.
• Solid understanding of GMP, ISO 13485, MDR-2017, ISO 14971, and EU IVDR.
• Experience working in a cross-functional environment with strong coordination and communication skills.
• Hands-on experience with quality processes such as document control, CAPA, risk management, and internal audits.
• Strong attention to detail and ability to manage multiple priorities effectively.

Work Environment:

• Office/lab environment; occasional support in manufacturing or testing areas.
• May require minimal travel for supplier audits or team coordination.