Senior Quality Assurance Executive

Role & responsibilities

• Implement and maintain ISO 13485-compliant QMS and continuously improve QA systems.
• Oversee incoming, in-process, and finished product quality for IVD raw materials (antigens, antibodies, reagents).
• Prepare and control SOPs, WIs, batch records, forms, and quality documentation.
• Manage deviations, non-conformances, CAPA, change controls, complaints, RCA, and risk assessment.
• Support internal, supplier, and regulatory/certification audits including ISO 13485 and CDSCO.
• Support CDSCO regulatory compliance, validation, and qualification activities.
• Collaborate with Production, R&D, and Regulatory teams to ensure quality across manufacturing.
• Build and strengthen QA processes in a startup environment, with a hands-on, adaptable approach.

Preferred candidate profile

• 5 years of hands-on QA experience, preferably in IVD raw materials, antigens, antibodies, or diagnostic reagents manufacturing.
• Candidates from medical device manufacturing without direct IVD experience may also be considered.
• Knowledge of GMP/GLP, biological raw materials, storage, handling, and cold-chain requirements is preferred.
• Exposure to ELISA, immunoassays, protein-based testing, and stability studies is an advantage.
• Basic understanding of ISO 14971 risk management and design controls preferred.
• Awareness of ISO 9001 and CE/IVDR/export quality requirements is an added advantage.