Sr. Engineer- Design Quality

Artech; Thiruvananthapuram; Vor Ort; INR 1.200.000 - 2.000.000; Vollzeit

Zusammenfassung

Artech in Trivandrum (Kerala) is seeking a Senior Design Quality Engineer (L3) in the medical devices domain to ensure QMS compliance, design controls, and regulatory adherence while supporting product development and design-to-manufacturing transfers.

The role involves reviewing technical documentation, risk management artifacts, and DHF, maintaining data integrity, and contributing to post-market data analysis and design verification/validation reviews.

Qualifikationen

• Senior Design Quality Engineer (L3) for medical devices.
• Ensure QMS compliance, design control, and regulatory adherence.
• Supports product development and design-to-manufacturing transfer.

Aufgaben

• Support design changes and new product development
• Review and approve technical documentation, DHF, and risk files
• Ensure data integrity and audit DHF records
• Create risk management documentation
• Analyze post-market and risk data
• Participate in design verification/validation reviews

Kenntnisse

Design Control

Risk Management

Medical Devices exp

Jobbeschreibung

Role- Sr. Engineer- Design Quality

Experience: 5+ Years

Location: Trivandrum (Kerala)

Mandatory Skil l:

• Design Control
• Risk Management
• Medical Devices exp

Role Overview

• Senior Design Quality Engineer (L3) for medical devices
• Ensures QMS compliance, design control, and regulatory adherence
• Supports product development and design-to-manufacturing transfer

Key Responsibilities

• Support design changes and new product development
• Review and approve technical documentation, DHF, and risk files
• Ensure data integrity and audit DHF records
• Create risk management documentation
• Analyze post-market and risk data
• Participate in design verification/validation reviews