Medical Device Quality Engineer: Design Controls & V&V

Katalyst CRO; Lake Forest (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer specialized in Medical Device quality to support R&D, Regulatory, and cross-functional teams in Lake Forest, CA. You will contribute to Design Controls, Risk Management, V&V activities, CAPA, and GxP compliance to ensure product quality from development through launch.

The role requires a Bachelor's in Engineering and 2+ years in Medical Device QA, with strong communication and problem-solving skills to collaborate across disciplines in a fast-paced

Qualifications

• Bachelor's degree in Engineering or related field.
• 2+ years of Medical Device Quality Engineering experience.
• Strong knowledge of Design Controls, Risk Management and Regulatory Compliance.

Responsibilities

• Support Medical Device Quality Engineering activities.
• Collaborate with R&D, Regulatory, and cross-functional engineering teams.
• Support Design Controls and Risk Management activities.
• Participate in Verification & Validation (V&V) activities.
• Support Change Control and CAPA processes.
• Ensure compliance with GxP requirements.
• Provide Product Development support.

Skills

Medical Device QA

Design Controls

Risk Management

V&V

Change Control

CAPA

GxP Compliance

Regulatory Compliance

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Job description

Katalyst CRO seeks a Quality Engineer specialized in Medical Device quality to support R&D, Regulatory, and cross-functional teams in Lake Forest, CA. You will contribute to Design Controls, Risk Management, V&V activities, CAPA, and GxP compliance to ensure product quality from development through launch.

The role requires a Bachelor's in Engineering and 2+ years in Medical Device QA, with strong communication and problem-solving skills to collaborate across disciplines in a fast-paced