About this opportunity
Creative Solutions Services, LLC lists this Quality Engineer opportunity in lake forest, California. Review the employer’s description below for duties, qualifications and application requirements.
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.
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Worksite address
lake forest, CA, 92630, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.