QA Executive – Diagnostics (ISO 13485)

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

Benefits offered by this job

Modern manufacturing environment

Regulatory exposure opportunities

Career growth in MedTech

Job summary

Arni Medica Private Limited seeks a Quality Assurance Executive – Diagnostics to implement ISO 13485 quality management across diagnostics products in Hyderabad. Drive document control, CAPA, audits and alignment with CDSCO MDR 2017.

Collaborate with R&D, Regulatory and manufacturing teams to ensure compliance and product quality. Candidates should have 2–6 years in QA/QMS for medical devices or IVD, with relevant degrees and a background in regulatory processes.

Qualifications

• 2–6 years of QA / QMS experience in medical devices or IVD diagnostics.
• ISO 13485 Internal Auditor / Lead Auditor certification is preferred.
• CDSCO licensing exposure (MD-05/MD-09) and eQMS software experience.
• IVD-reagent QA background 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).] ,
• CoT_job_summary_short
• COMPANY NAME: Arni Medica Private LimitedKEY POINTS: QA/QMS in medical devices, ISO 13485, CDSCO MDR exposure, Hyderabad on-site role
• job_summary_short
• <p>Arni Medica Private Limited is seeking a Quality Assurance Executive – Diagnostics to implement and maintain QMS for diagnostic products in line with ISO 13485:2016 and CDSCO MDR 2017. The role spans document control, audits, CAPA, and quality-system coordination across functions.</p><p>The ideal candidate has 2–6 years of QA / QMS experience in medical devices or IVD diagnostics, with relevant degrees and regulatory exposure. On-site work in Hyderabad offers growth in a fast-growing MedTech company.</p>
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• fulltime
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• on site
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• QA Executive in Hyderabad market range: INR 6–9 LPA gross annually based on experience and band.
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• Quality Assurance

Skills

QA / QMS experience

ISO 13485

CDSCO MDR 2017

IVD QA background

Education

B.Pharm / M.Pharm

B.Sc / M.Sc (Life Sciences, Microbiology, Biotech, Chemistry)

B.E./B.Tech (Biomedical)

Tools

eQMS software

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.