Quality Engineer I in Bangalore, भारत

Entry-level quality engineering position ensuring medical device products meet established requirements and regulatory standards. The role involves cross-functional collaboration on compliance, documentation, risk management, and continuous quality improvement activities.

Responsibilities

• Ensure product compliance with global regulations and quality standards
• Review, maintain, and approve Design History Files and Risk Management Files
• Identify and mitigate design risks using FMEA and analytical tools
• Support design verification, validation, and change control processes
• Manage nonconformance records, investigate complaints, and support CAPA activities

Requirements

• Bachelor's degree with 1-3 years related experience
• Familiarity with 21 CFR 820, ISO 13485, IEC 62304 standards
• Experience in regulated industries
• Medical device industry experience preferred
• Proficiency with MS Office Suite and Adobe software