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Quality Assurance Engineer – Surgical Devices

Healthium Medtech

Full-time Onsite India

Job Description

About This Role

Healthium Medtech — India's largest surgical consumables company — is hiring fresh engineering graduates as Quality Assurance Engineers to maintain quality standards across its manufacture of surgical sutures, wound closure devices, and surgical instruments exported globally.

Key Responsibilities

  • Perform in-process and final product quality inspection for surgical sutures, needles, skin staplers, and wound closure devices
  • Execute acceptance sampling plans per AQL standards and statistical quality control methodologies
  • Investigate non-conformances (NCRs) and customer complaints — root cause analysis and corrective action implementation
  • Support internal quality audits and external regulatory audits (CE, ISO 13485, US FDA)
  • Maintain quality documentation — SOPs, batch manufacturing records, test certificates, and stability reports
  • Assist in process validation and new product qualification activities for new surgical device lines

Requirements & Skills

  • B.E./B.Tech in Biomedical Engineering, Mechanical, or Production Engineering — 2024/2025 batch
  • Understanding of ISO 13485 QMS, GMP, and medical device regulatory requirements
  • Knowledge of statistical quality control (SPC, AQL, MSA) tools
  • Strong attention to detail, systematic documentation habits, and quality mindset
  • Proficiency in MS Office for quality data recording and analysis

Benefits & Work Conditions

  • Competitive fresher salary
  • Structured QA training on medical device quality systems
  • Health insurance and PF
  • Exposure to export-compliant medical device manufacturing for global markets
  • Career growth into quality systems, regulatory affairs, or operations management

About the Company

Healthium Medtech (formerly Sutures India) is India's largest surgical consumables manufacturer, producing sutures, wound care products, and surgical instruments distributed to hospitals in 90+ countries. As an Apax Partners portfolio company, Healthium combines Indian manufacturing expertise with global quality standards — offering freshers rigorous quality engineering experience in a globally certified medical device environment.

How to Apply

Apply at healthium.com/careers. Browse Quality and Engineering roles and apply for entry-level QA Engineer positions at Healthium's Bengaluru facilities.

Job Details

Salary ₹3 – ₹6 / month
Job Type Full-time
Work Mode Onsite
Location Bengaluru, Karnataka
Apply Before Jul 14, 2026
Important: We never charge any fee at any stage of the hiring process. If anyone asks for money, report it to [email protected].