Medical Device Quality Engineer – Design Controls

Katalyst-Healthcares-; Lake Forest (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineer in the Medical Device field to support innovative healthcare products and collaborate with R&D, Regulatory, and cross-functional engineering teams in Lake Forest, CA.

The role requires strong knowledge of ISO 13485, ISO 14971, Design Controls, Risk Management, V&V, Change Control, CAPA and GxP compliance, with duties spanning documentation, product development support, and ensuring device quality throughout the lifecycle.

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.
• Excellent communication and problem-solving skills.

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

Quality Engineering

Risk Management

GxP Compliance

V&V

Change Control

CAPA

Regulatory Knowledge

Education

Bachelor's degree in Engineering

Job description

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.