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QA Executive Diagnostics (ISO 13485)

ARNI MEDICA PRIVATE LIMITED
Posted on
ARNI MEDICA PRIVATE LIMITED logo
Experience
2 - 6 yrs
Job Location
India
Vacancy
1
Designation
QA Executive
Job Type
Not specified

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
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.
Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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