Lead Quality Engineer – Medical Devices

Emugtech; Pune District; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

EMUG Engineering Services in Pune seeks an experienced Lead Quality Engineer to head quality management across medical device development projects. You will oversee software development, QMS implementation, and regulatory compliance including EU MDR, ISO 13485, and IEC 62304.

The role requires guiding a sizeable quality team, driving data-based improvements, and collaborating with delivery heads and BU leadership to ensure high-quality outputs.

Job description

Location: Pune
Experience: 15+ Years
Employment Type: Full-time

Job Overview

EMUG Engineering Services is looking for an experienced Lead Quality Engineer to lead quality management, regulatory compliance, process improvement, and quality initiatives across medical device development projects. The role requires strong experience in medical devices, software development, QMS, EU MDR, and team management.

Roles & Responsibilities

• Lead and manage quality activities across medical device product and software development projects.
• Ensure compliance with applicable medical device regulations, standards, and quality processes.
• Manage and mentor a sizeable quality team, providing technical and process guidance.
• Drive compliance with ISO 13485, ISO 14971, IEC 62304, EU MDR, and other relevant standards.
• Work closely with customers and manage customer communication and quality-related requirements.
• Analyze quality metrics and KPIs and drive data-based improvement initiatives.
• Lead process improvement initiatives across business units and customer accounts.
• Provide training on QMS, processes, regulatory standards, and quality practices.
• Work closely with delivery teams, delivery heads, and BU management.
• Support and drive organization-level and BU-level quality and process improvement programs.
• Ensure effective implementation and continuous improvement of the Quality Management System.

Required Skills & Experience

• 15+ years of overall experience in quality engineering, preferably in the medical device industry.
• At least 5 years of experience in team management and leadership.
• Strong knowledge of the medical device industry and regulatory compliance.
• Experience managing medical device product development and software development projects.
• Strong experience with EU MDR and medical device regulatory requirements.
• In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and other relevant medical device standards.
• Strong experience in QMS, metrics analysis, quality improvement, and process management.
• Excellent communication, customer management, mentoring, and leadership skills.
• Ability to independently manage and mentor large teams.
• Experience working with delivery teams, BU leadership, and management.

Preferred Certifications

• ISO 13485 Lead Auditor
• MDSAP
• Other relevant medical device quality and regulatory certifications.

Bachelor's or Master's degree in Engineering, Life Sciences, Pharmacy, Medical Devices, Quality Management, or a related field.