QA Executive – Diagnostics (ISO 13485) – On-Site

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

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.