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Nidek Medical India
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Quality Analyst

Quality Analyst

Nidek Medical India

2 - 5 years

1 - 4 Lacs

Calcutta

Posted:1 month ago| Platform: GlassDoor logo

Apply

Skills Required

engineering biotechnology compliance communication healthcare regulations management audits risk design development controls planning verification inspection maintenance traceability training

Work Mode

On-site

Job Type

Full Time

Job Description

Minimum Qualification:

Degree in Biomedical Engineering / Biotechnology / Life Sciences.
Preferred / Advanced Master’s Degree (MSc, MBA with QA focus, or Regulatory Affairs).

Requirements and skills:

Must have Technical & Regulatory Knowledge.
Quality & Compliance along with Technical skills.
Communication, Critical Thinking, Organizational, Attention to Detail.

Work Experience:

2–5 years in quality or regulatory affairs in a healthcare segment.
Experience with FDA or ISO inspections/audits.

Work Profile:

Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc)
Quality Management System - Document and record control, management responsibility, internal audits, corrective and preventive actions, risk management.
Design and Development Controls - Design planning, input/output verification, validation, review, history file.
Process Control - Process validation, inspection, maintenance, traceability of final product.
Complaint Handling and Market Surveillance - Collecting, reviewing, and responding to customer complaints, field safety corrective actions and recalls, clinical follow-up.
Training and Competence - Maintain up-to-date training records, periodically reassess competencies.
Risk Management.

Job Types: Full-time, Permanent

Pay: ₹10,109.64 - ₹34,105.43 per month

Benefits:

Leave encashment
Provident Fund

Schedule:

Day shift

Work Location: In person

Application Deadline: 12/07/2025
Expected Start Date: 14/07/2025

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