Lead Quality Engineer - Medical Devices

e mug; Pune District; On-site; INR 4,000,000 - 6,400,000; Full time

Job summary

EMUG Engineering Services in Pune seeks a Lead Quality Engineer to head quality management across medical device development, software, and QMS compliance, while leading a sizeable quality team.

The role requires 15+ years in quality engineering in medical devices, with 5+ years in leadership, and deep knowledge of ISO 13485, ISO 14971, IEC 62304, and EU MDR compliance.

Qualifications

• 15+ years of quality engineering experience in medical devices.
• Minimum 5 years of team leadership experience.
• Strong knowledge of medical device regulations and standards.
• Experience in medical device software development and QMS.
• Experience with EU MDR compliance.

Responsibilities

• Lead quality activities across medical device product and software development projects.
• Ensure compliance with medical device regulations, standards, and quality processes.
• Mentor a sizeable quality team.
• Drive ISO 13485, ISO 14971, IEC 62304, EU MDR compliance.
• Collaborate with customers on quality requirements.
• Analyze metrics and KPIs to drive improvements.
• Lead process improvement initiatives across units.
• Provide training on QMS and regulatory standards.
• Work with delivery teams and BU management.
• Support organization-wide quality programs.
• Ensure effective implementation and continuous improvement of QMS.

Skills

Quality leadership

Medical devices

Regulatory compliance

EU MDR

Team management

QMS

ISO 13485

IEC 62304

ISO 14971

Metrics analysis

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.

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.