QA Executive – Diagnostics (ISO 13485)

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 460,000 - 723,000; Full time

Job summary

Arni Medica Private Limited seeks a QA Executive to support the implementation and maintenance of the quality management system for diagnostics products, aligned with ISO 13485:2016 and CDSCO MDR 2017. This onsite Hyderabad role spans document control, CAPA and cross‑functional quality coordination.

The ideal candidate has 2–6 years in QA/QMS within medical devices or IVD, with strong attention to detail and the ability to drive compliance across functions in a fast‑growing MedTech company.

Qualifications

• 2–6 years of QA / QMS experience in medical devices or IVD diagnostics.
• ISO 13485:2016 knowledge is essential.
• CDSCO MDR 2017 familiarity is preferred.

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).

Skills

QA/QMS experience

Medical devices

Education

B.Pharm / M.Pharm

B.Sc / M.Sc (Life Sciences)

B.E./B.Tech (Biomedical)

Job description

Patancheru, India | Posted on 08/27/2026

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.

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.