Quality Engineer

Katalyst CRO; Santa Clarita (CA); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer with 4–6 years in medical device quality engineering to support DV&V, design controls, risk management, and regulatory compliance throughout product development.

Responsibilities include reviewing verification protocols, executing test method validations, and collaborating with cross-functional teams to drive quality improvements. Experience with FDA/ISO 13485 is preferred.

Qualifications

• 4–6 years of experience in medical device quality engineering.
• Experience with DV&V (design verification & validation).
• Knowledge of design controls and risk management (dFMEA).
• Familiarity with test method validation and DHR documentation.
• Experience with regulatory requirements (FDA/ISO 13485) preferred.

Responsibilities

• Review design verification protocols, reports, and summary documentation.
• Evaluate test method validations, fixtures qualifications, and regression analyses.
• Support risk management activities, including dFMEA reviews.
• Review build protocols, DHRs, configuration changes, and design controls deliverables.
• Assist installation qualification for software and test equipment.
• Collaborate with cross-functional teams on defect tracking and quality improvements.
• Review design changes and inspection plans for components and sub-assemblies.

Skills

Quality Engineering

DV&V

Design Controls

Risk Management

Test Method Validation

DHR Review

New Product Development

Regulatory Compliance

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.