Quality Assurance Executive – Diagnostics (ISO 13485)

About the role

The Quality Assurance Executive will support the implementation and maintenance of the quality management system for diagnostics products, ensuring compliance with ISO 13485:2016 and CDSCO MDR 2017. This role involves document control, audit support, batch‑record review, CAPA management and coordination across functions.

Key responsibilities

• Maintain and implement the QMS per ISO 13485:2016 and ensure CDSCO MDR 2017 compliance.
• Control SOPs, work instructions, specifications, batch records, change control and quality records.
• Manage CAPA, customer complaints, root‑cause analysis, deviations and non‑conforming product (NCR).
• Plan and support internal audits, supplier audits and external inspections; track findings to closure.
• Maintain DHF, DMR and DHR; review production and release documentation for diagnostics reagents.
• Support Management Review, quality objectives/KPIs, ISO 14971 risk management, training compliance and process validation (IQ/OQ/PQ).

Required profile

• B.Pharm / M.Pharm, B.Sc / M.Sc (Life Sciences, Microbiology, Biotech, Chemistry) or B.E./B.Tech (Biomedical).
• 2–6 years of QA/QMS experience in medical devices or IVD diagnostics.

Required skills

• ISO 13485:2016, ISO 14971, CDSCO MDR 2017.
• 21 CFR 820, 21 CFR Part 11.
• CAPA, NCR, change control, document control.
• Internal & supplier audit, root‑cause analysis.
• DHF, DMR, DHR management.
• Risk management, process validation (IQ/OQ/PQ), complaint handling.
• EU IVDR awareness, ISO 13485 Internal Auditor certification.
• CDSCO licensing exposure, eQMS software experience.

What we offer

• Opportunity to build a greenfield IVD diagnostics business from the ground up.
• Modern ISO‑compliant manufacturing environment with cleanroom infrastructure.
• Direct collaboration with R&D, regulatory and senior leadership.
• Competitive compensation commensurate with experience.
• Accelerated career growth in a fast‑scaling, export‑oriented MedTech company.