Avensys is a reputed global IT qualified services company headquartered in Singapore. Our service spectrum includes enterprise solution consulting, business intelligence, business process automation and managed services. Given our decade of success, we have evolved to become one of the top trusted providers in Singapore and service a client base across banking and financial services, insurance, information technology, healthcare, retail and supply chain

Title: Design Quality Engineer

Location: Pune, Gurgaon

Your Role

As a Design Quality Engineer in the medical device domain, you will be responsible for ensuring end-to-end product quality and regulatory compliance through design control, risk management, validation, and supplier quality activities across the product lifecycle

In this role, you will:

• Coordinate design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage.





• Support Design Control activities by ensuring compliance with FDA and international regulations.

• Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments.

• Review protocols and participate in V&V; planning to ensure alignment with product requirements.

• Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.

• Support Design Control activities by ensuring compliance with FDA and international regulations.

• Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures and operator self-inspection procedures.

• Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging.

• Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ)

📌 Design Quality Engineer (Pune)
🏢 Avensys Consulting
📍 Pune