Lead Quality Engineer - Medical Devices
e-MUG Engineering Services Pvt Ltd · Pune · onsite · Posted 27d ago
Undisclosed15–20 yrsfulltimeSourced from
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About this role
Location: Pune
Experience: 15+ Years
Employment Type: Full-time
Job Overview Experience: 15+ Years
Employment Type: Full-time
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 .
- 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 .
- 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.
Sourced from naukri
Skills
Quality EngineerISO 13485quality improvementProcess ImprovementCustomer ManagementMedical Device RegulationsMedical Device StandardsQuality EngineeringMedical DevicescomplianceProduct DevelopmentProcess Management
About e-MUG Engineering Services Pvt Ltd
e-MUG Engineering Services Pvt Ltd
Engineering & Construction
175
employees
2001
25 years old
Hyderabad / Secunderabad, Telangana
IN
₹5.2L PA avg
Avg at e-MUG Engineering Services Pvt Ltd
About
e-mug Technologies offers engineering services with a focus on continuous improvement and innovation, catering to multiple industrial sectors globally.
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Engineering & Construction
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