Quality Engineer I - Instrumentation Quality Engineer

Req# 10353-1

Req Number:

10353-1

Req Title:

Quality Engineer I - Instrumentation Quality Engineer

Client:

A Major Pharma Company

Work Address:

Lake Forest, CA

Req Release Date:

05/26/2026

Duration:

6 months Hours a week: 40 Hours Position Summary 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.

Qualifications:

Minimum:

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:

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.