Quality Engineer - Medical Devices

Role overview

This position is for a Quality Engineer focused on medical devices, based in Pune Division, Maharashtra. The role involves supporting quality engineering across the product lifecycle, with strong exposure to regulatory compliance, design assurance, risk management, and validation activities.

Quality and regulatory knowledge

The ideal candidate should be familiar with quality management systems and medical device regulations, including CFR 820, ISO 13485, ISO 14971, and IEC 60601. Practical experience with risk management, post-market surveillance, complaint handling, design planning, deviation management, and CAPA is preferred.

Key responsibilities

• Work as part of the core project team and contribute to quality engineering throughout the full development cycle.
• Drive product risk management, usability, reliability, and design validation for new product development and design change initiatives.
• Plan and execute design verification and validation activities in coordination with the project design lead.
• Develop Critical to Quality (CTQ) requirements, along with design input and design output documentation.
• Handle fixture qualification and validation of test methods.
• Support and implement DOE, FMEA, and risk management activities while ensuring alignment with CTQ and safety requirements.
• Maintain electronic document control and version tracking for all project-related records.
• Ensure compliance with quality system procedures and design assurance SOPs.
• Lead usability, reliability, verification, and validation testing with internal teams and local vendors.
• Prepare statistical testing and product reliability plans.
• Offer quality and regulatory guidance to development and design change teams to help meet country-specific compliance requirements for target markets.
• Ensure that all project and sustaining quality deliverables are prepared and executed correctly, including design and development plans, risk management plans, hazard analyses, FMEAs, field assessment plans, and software validation plans where applicable.
• Co-lead CAPA actions and apply structured problem-solving techniques such as 5 Whys, Is-Is Not analysis, and Six Sigma methods to identify, prioritize, communicate, and resolve quality issues.
• Develop and support quality assurance measures, process controls, statistical analysis, and performance metrics to ensure products meet or exceed quality expectations.

Additional requirements

Hands-on experience with risk management is important. Exposure to post-market surveys, complaint handling, design planning, process deviation handling, and CAPA is also desirable.

Work location

This is an onsite role in Pune Division, Maharashtra, India.