Medical Device Quality Engineer — DV&V & Risk Mgmt

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

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.