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Professional - Engineering - Quality Engineer I

Job

Mindlance

Lake Forest, CA (In Person)

Full-Time

Posted 5 days ago (Updated 2 days ago) • Actively hiring

Expires 7/4/2026

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Professional

Engineering
Quality Engineer I#26-15504 Lake Forest, CA Onsite Job Description
Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation products
Ensure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activities
Partner with project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forward
Review and approve design control deliverables, including risk management files, verification and validation documentation, and related development records
Evaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementation
Partner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as needed
Maintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices Minimum Qualifications
Bachelor's degree in engineering, life sciences, or a related technical field
2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an

environment

Experience with design controls, change control, and product impact assessments
Working knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, design controls and GxP principles
Ability to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-up
Experience with risk management in accordance with

Experience reviewing or supporting verification and validation protocols, reports, and related documentation Preferred Qualifications
Statistical knowledge to support sample size determination and the design of verification and validation studies
Working knowledge of applicable product and safety standards, such as the

series and

ASQ Certified Quality Engineer (CQE) certification
Six Sigma Green Belt or higher
Strong communication, organization, collaboration, and independent problem-solving skills

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of