Quality Engineer

• We are Seeking a medical device product development, design verification, and quality engineering support with 4 6 years of experience in Quality Engineer.
• The ideal candidate will support design verification activities, risk management, design control processes, and quality compliance throughout the product development lifecycle.

Responsibilities:

• Review and support design verification protocols, reports, and summary documentation.
• Evaluate test method validations, test fixture qualifications, and regression analysis.
• Support risk management activities, including dFMEA reviews and impact assessments.
• Review build protocols, DHRs, configuration changes, and design control deliverables.
• Support installation qualification (IQ) activities for software and test equipment.
• Collaborate with cross-functional teams on defect tracking, test execution, and quality improvements.
• Review mechanical/electrical design changes and inspection plans for components and sub-assemblies.

Requirements:

• Medical Device Quality Engineering.
• Design Verification & Validation (DV&V).
• Design Controls.
• Risk Management (dFMEA).
• Test Method Validation.
• DHR Review & Documentation.
• New Product Development (NPD).
• Regulatory Compliance & Quality Systems.

Preferred Skills:

• FDA/ISO 13485 Medical Device Regulations.
• Product Development Lifecycle.
• Cross-Functional Quality Support.

Experience:

• 4 6 Years in Medical Device Quality Engineering or Product Development Quality.