Job Title: Quality Assurance Executive – Diagnostics (ISO 13485)
Location: Hyderabad, India
Department: Quality Assurance
Experience: 2–6 years (QA / QMS in medical devices or IVD)
Employment Type: Full-time, in office

About Arni Medica
Arni Medica Private Limited is an ISO 13485:2016 and ISO 9001:2015 certified medical device and in-vitro diagnostics (IVD) manufacturer based at the Medical Devices Park, Sangareddy (Hyderabad), Telangana. We design and manufacture nephrology, infusion therapy, respiratory care and surgical disposables, and are building a full IVD diagnostics franchise spanning clinical chemistry, electrolyte/ISE, blood gas (ABG), fluorescence immunoassay (FIA) and chemiluminescence immunoassay (CLIA) platforms — backed by Class 100K/10K cleanrooms, EtO sterilization and a CDSCO manufacturing licence (MFG/MD/2023/000942).

Role Overview
The QA Executive will support implementation and maintenance of the quality management system for diagnostics products in compliance with ISO 13485:2016 and CDSCO MDR 2017. The role spans document control, audit support,



batch-record review, CAPA and quality-system coordination across functions.

Key Responsibilities
• Maintain and implement the QMS per ISO 13485:2016; 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).

Desired Candidate Profile
• Education: B.Pharm / M.Pharm, B.Sc / M.Sc (Life Sciences, Microbiology, Biotech, Chemistry) or B.E./B.Tech (Biomedical).
• Experience: 2–6 years of QA / QMS

📌 QA Executive – Diagnostics (Hyderabad)
🏢 Arni Medica
📍 Hyderabad