Quality Engineer

Katalyst Healthcares and Life Sciences

Lake Forest, CA

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.

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Vacancy posted 1 day ago

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