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 workplace, 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.

📌 Senior Quality Assurance Executive Navi Mumbai (India)
🏢 Humaquest Consulting
📍 India