QA Executive – Diagnostics (ISO 13485)
Summary
Quality Assurance Executive maintaining the ISO 13485 quality management system for in-vitro diagnostics (IVD) products at a medical device manufacturer near Hyderabad — handling document control, CAPA, internal/supplier audits, batch-record review, and CDSCO MDR 2017 / ISO 14971 compliance. On-site, full-time.
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 MedTech company.
How to Apply
Email your CV to jobs@arnimedica.com with the position title in the subject line.