Quality Engineer - Medical Devices

Location: Pune
Experience: 3-6 Years
Employment Type: Full-time

Job Overview

EMUG Engineering Services is looking for a Quality Engineer with experience in Medical Device Quality Management Systems (QMS) , regulatory compliance, audits, CAPA, risk management, and design controls.

Roles Responsibilities

• Implement, maintain, and improve the Medical Device QMS in compliance with ISO 13485, FDA 21 CFR 820 , and applicable regulatory requirements.
• Ensure software lifecycle processes comply with IEC 62304 .
• Support medical device design and development in accordance with ISO 13485, ISO 14971, and IEC 62304 .
• Support New Product Development (NPD) and design control activities.
• Prepare, review, and control QMS documentation, including SOPs, procedures, records, and forms .
• Manage Document Control, Change Control, and Training Records .
• Plan and conduct internal audits and support external audits, including Notified Body and FDA audits.
• Manage CAPA, non-conformances, deviations, and root cause analysis (RCA) .
• Support Risk Management activities in accordance with ISO 14971.
• Coordinate Management Review Meetings and prepare reports.
• Ensure compliance across Design Controls, Production, and Quality Control activities.
• Analyze quality metrics, KPIs, and SLAs , including RCA and CAPA.
• Support Verification Validation (VV) activities for medical devices and products.

Education Skills

• Bachelor s degree in Engineering, Pharmacy, Life Sciences, or an equivalent field .
• 3-6 years of experience in Medical Device QMS.
• Strong knowledge of ISO 13485, ISO 14971, and IEC 62304 .
• Experience in audits, CAPA, RCA, documentation, and quality management .
• Good communication and technical documentation skills.
• ISO 13485 Internal/Lead Auditor certification will be an advantage.
• Exposure to Medical Device Design Control documentation .

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.