Quality Engineer

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

• We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
• The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.
• 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.

Job Summary

• We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
• The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.

Roles & 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.

Education & Experience

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