Quality Engineer (Design control, Medical devices)

Job Title: Instrumentation Quality Engineer

Location: Lake Forest, CA - onsite

Contract Length: 6 months with potential to be extended

About the Role:

In this role, you will work closely with R&D, Regulatory, Operations, and other cross-functional stakeholders to provide hands-on quality engineering support across the product development lifecycle. You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer. The ideal candidate brings strong technical judgment, demonstrated quality capability, and the ability to operate independently in a fast-paced environment.

Major Accountabilities:

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 ISO 13485 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 ISO 14971

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 IEC 60601 series and ISO 14971

ASQ Certified Quality Engineer (CQE) certification

Six Sigma Green Belt or higher

Strong communication, organization, collaboration, and independent problem-solving skills