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Quality Engineer

Karwell Technologies

Santa Clarita, CA

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JOB DETAILS
SKILLS
Analysis Skills, Bug Tracking/Defect Management, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Documentation, Electrical Design, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), Mechanical Design, Medical Equipment, Medical Products, Product Development, Product Lifecycle, Protocol Design, Quality Assurance Methodology, Quality Control, Quality Engineering, Regulations, Regulatory Compliance, Risk Management, Software Testing, Test Equipment, Testing, Validation Testing
LOCATION
Santa Clarita, CA
POSTED
30+ days ago
Job Description:
  • 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.

About the Company

K

Karwell Technologies