QA Executive – Diagnostics (ISO 13485)

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, on-site 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 experience in medical devices or IVD diagnostics. Technical Skills & Keywords ISO 13485:2016, ISO 14971, CDSCO MDR 2017, 21 CFR 820 / QSR / QMSR, 21 CFR Part 11, CAPA, NCR, change control, document control, internal & supplier audit, DHF / DMR / DHR, risk management, process validation (IQ/OQ/PQ), complaint handling, EU IVDR awareness.

Preferred / Good to Have ISO 13485 Internal Auditor / Lead Auditor certification CDSCO licensing exposure (MD-05/MD-09) and eQMS software experience. IVD-reagent (not only device) QA background.

What We Offer

A rare opportunity to help build a greenfield IVD diagnostics business from the ground up. Modern, ISO 13485 / CDSCO-compliant manufacturing environment with cleanroom infrastructure. Direct collaboration with R&D, Regulatory and senior leadership — visible impact, fast decisions. Competitive compensation, commensurate with experience (negotiable; as per industry standards).

Accelerated career growth in a fast-scaling, export-oriented Med. Tech company. How to Apply Email your CV to jobs@arnimedica.com with the position title in the subject line.