QA Executive – Diagnostics (ISO 13485)

Arni Medica Pvt Ltd.; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive compensation

Career growth opportunities

Export-oriented MedTech company

Job summary

Arni Medica Pvt Ltd seeks a Quality Assurance Executive for Diagnostics to implement and maintain the ISO 13485:2016 QMS and ensure CDSCO MDR 2017 compliance in a fast-growing diagnostics manufacturing environment.

Role spans document control, audits, CAPA, and cross-functional quality-system coordination across R&D, Regulatory and production teams, with career growth in a regulated MedTech setting.

Qualifications

• 2–6 years of QA / QMS experience in medical devices or IVD diagnostics.
• ISO 13485 Internal Auditor / Lead Auditor certification preferred.
• CDSCO licensing exposure and eQMS software experience.
• IVD-reagent QA background.

Responsibilities

• Maintain 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

ISO 13485

Internal Auditor

Lead Auditor

Education

B.Pharm / M.Pharm

B.E./B.Tech Biomedical

Tools

eQMS software

CDSCO licensing exposure

Job description

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

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.