Software Quality Engineer

Meril; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Meril is seeking a highly motivated Quality Engineer to join its NPD Quality team in a cross-functional role supporting design assurance, risk management, and validation activities for medical device products.

You will collaborate with Design Engineering, Test Engineering, Advanced Operations, Manufacturing, and Regulatory Affairs to ensure development, transfer, and commercialization of high-quality devices, with a strong focus on compliance and continuous improvement throughout the product

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, manufacturing engineering or related field.
• 5–7 years of experience in Quality Engineering, Design Assurance or Product Development in medical devices.
• Experience supporting New Product Development (NPD) in a regulated medical device environment.
• Strong understanding of Design Controls and Risk Management principles.
• Experience preparing and reviewing quality and design documentation.
• Excellent analytical, communication, and organizational skills.
• Proven ability to manage priorities in cross-functional settings.

Responsibilities

• Support Design Assurance activities across the product development lifecycle.
• Ensure compliance with Design Control requirements (FDA QSR/QMSR, ISO 13485).
• Prepare, review, and maintain Design History File documentation.
• Review requirements, design outputs, verifications, validations, and traceability.
• Support quality systems and tools like Jama, Integrity, Matrix.
• Lead and support Risk Management activities per ISO 14971.
• Develop and maintain Risk Management Files during development and transfer.
• Facilitate DFMEA, PFMEA, and UFMEA analyses.
• Ensure manufacturing processes are capable and controlled before launch.
• Support supplier qualification and supplier quality strategies.

Skills

Quality Engineering

Design Assurance

Risk Management

Regulatory Compliance

Process Validation

Usability Engineering

Supplier Quality

Education

Biomedical Engineering

Mechanical Engineering

Electrical Engineering

Manufacturing Engineering

Tools

Jama

Integrity

Matrix

Job description

We are seeking a highly motivated and collaborative Quality Engineer to join our New Product Development (NPD) Quality team. In this role, you will partner with Design Engineering, Test Engineering, Advanced Operations, Manufacturing, Regulatory Affairs, and other cross-functional teams to ensure the successful development, transfer, and commercialization of high-quality medical devices products.

The Quality Engineer will provide leadership and technical expertise in Design Assurance, Risk Management, Design Controls, Process Validation, Usability Engineering, Supplier Quality, and Manufacturing Quality, ensuring compliance with applicable regulatory requirements and quality standards throughout the product lifecycle.

Who We Are Looking For

We are looking for individuals who are:

• Self-directed initiators who take ownership of their work, proactively identify opportunities for improvement, and consistently deliver high-quality results.
• Collaborative partners who build strong cross-functional relationships and effectively communicate with internal and external stakeholders.
• Analytical problem solvers who investigate root causes, evaluate data-driven solutions, and implement sustainable corrective and preventive actions.

Key Responsibilities

Design Assurance

• Support Design Assurance activities throughout the medical device product development lifecycle.
• Ensure compliance with Design Control requirements in accordance with FDA QSR/QMSR, ISO 13485, and applicable regulatory requirements.
• Support preparation, review, and maintenance of Design History File (DHF) documentation.
• Review product requirements, design outputs, verification, validation, and traceability documentation.
• Support implementation and migration of quality systems and tools (e.g., Jama, Integrity, Matrix, or equivalent).
• Lead and support Risk Management activities in accordance with ISO 14971.
• Develop and maintain Risk Management Files throughout product development and manufacturing transfer.
• Facilitate and review Functional Analysis, Hazard Analysis, dFMEA, pFMEA, and uFMEA.
• Support Critical Quality Attribute (CQA) identification.
• Ensure appropriate risk controls are identified, implemented, verified, and documented.
• Evaluate manufacturing and process risks and ensure effective mitigation throughout the manufacturing lifecycle.

Validation & Usability Engineering

• Support development and maintenance of Usability Engineering Files in accordance with IEC 62366-1.
• Participate in usability studies, formative evaluations, and validation activities.
• Review and approve validation protocols, reports, and statistical analyses.
• Support Design Verification, Design Validation, Process Validation, Software Validation, Computer System Validation, and Sterilization Validation activities as applicable.
• Partner with Advanced Operations and Manufacturing teams during design transfer.
• Ensure manufacturing processes are capable, controlled, and compliant before product launch.
• Support supplier qualification and supplier quality strategies.
• Review supplier validations, PPAP activities, and incoming quality requirements.
• Collaborate with suppliers to ensure components and manufacturing processes meet specified quality requirements.
• Participate in supplier performance monitoring and continuous improvement initiatives.

What you need:

• Bachelor’s degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related engineering discipline.
• Minimum 5-7 years of experience in Quality Engineering, Design Assurance, or Product Development within the medical device industry.
• Experience supporting New Product Development (NPD) in a medical device regulated environment.
• Strong understanding of medical device Design Controls and Risk Management principles.
• Experience preparing and reviewing quality and design documentation.
• Excellent analytical, communication, and organizational skills.
• Demonstrated ability to independently manage priorities and deliver results in cross-functional environments.

Why Join Us?

This role provides the opportunity to contribute to the development of innovative medical device technologies while working with multidisciplinary teams in a highly collaborative environment. You will play a critical role in ensuring that our products are safe, effective, compliant, and successfully transferred into manufacturing, ultimately improving the quality of life for people across the globe.