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Katalyst Healthcares & Life Sciences

Quality Engineer

Pay: Not specified

Posted: 5 weeks ago

Location: Lake Forest, CA (Onsite)

Last Updated: 1 week ago

Hours: Full-Time

Expires: 10/4/2026

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What they do

A Quality Engineering Manager interfaces with customers, suppliers, and various company departments to resolve quality problems and develop strategic quality improvement activities. Responsible for building strong relationships with the global customer quality organizations to ensure customer support and product performance through continuous improvement.

$183,235 / year median in California

+5% projected growth

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Job Description

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.