Quality Engineer – Medical Devices

Emugtech; Pune District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

EMUG Engineering Services seeks a Quality Engineer with experience in Medical Device QMS, regulatory compliance, audits, CAPA, risk management, and design controls. The role focuses on implementing and maintaining QMS per ISO 13485 and FDA requirements, ensuring IEC 62304 software lifecycle conformance, and supporting NPD with documentation control.

The candidate will lead internal audits and assist external audits, manage CAPA and RCA activities, and coordinate risk management per ISO 14971

Qualifications

• 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.
• ISO 13485 Internal/Lead Auditor certification will be an advantage.
• Exposure to Medical Device Design Control documentation.

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 (V&V) activities for medical devices and products.

Skills

QMS

Regulatory compliance

Internal audits

CAPA

RCA

ISO 13485

ISO 14971

IEC 62304

Documentation

V&V

Education

Bachelor’s degree in Engineering, Pharmacy, Life Sciences

Job description

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 (V&V) 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.

Bachelor's degree in Engineering, Pharmacy, Life Sciences, or an equivalent field.