Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Lake Forest, CA Job Details Contract 20 hours ago Qualifications GxP Preventive action implementation Engineering Regulatory compliance Quality control preventive actions Corrective and preventive actions (CAPA) Mid-level Collaboration with product development teams Bachelor's degree in engineering Quality risk management Product development System validation Design controls Biomedical regulatory compliance 2 years Healthcare compliance Communication skills

ISO 13485

Cross-functional communication Engineering quality assurance

Full 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.