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SRG

Quality Engineer

irvine, CA

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About this opportunity

SRG lists this Quality Engineer opportunity in irvine, California. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Our client, a medical device manufacturer, is seeking a Quality Test Engineer to support root-cause investigations for customer complaints and drive corrective and preventive actions. This is a hands-on lab-based role (gloves/PPE, not a full cleanroom) with direct exposure to electrical testing, complaint investigations, and cross-functional quality improvement projects. This is an excellent opportunity for an early-career quality/test engineer to build depth in complaint investigation, risk assessment, and regulated medical device testing.

Key Responsibilities

About the Role

Our client, a medical device manufacturer, is seeking a Quality Test Engineer to support root-cause investigations for customer complaints and drive corrective and preventive actions. This is a hands-on lab-based role (gloves/PPE, not a full cleanroom) with direct exposure to electrical testing, complaint investigations, and cross-functional quality improvement projects. This is an excellent opportunity for an early-career quality/test engineer to build depth in complaint investigation, risk assessment, and regulated medical device testing.

Key Responsibilities

Investigate customer complaints related to product design, manufacturing, and testing

Document non-conformances (NCs) and support formal investigations

Perform electrical testing on medical devices as part of complaint resolution

Participate in CAPA trending meetings and contribute to root-cause and corrective action efforts

Apply risk assessment principles to evaluate product and process issues

Analyze data using engineering principles to support continuous improvement initiatives

Support internal and external quality audits

Communicate quality trends and business-impacting issues to management

Comply with all applicable federal, state, local, and company health, safety, and environmental regulations

Qualifications

Bachelor's degree in Engineering

2+ years of experience in an engineering-related field (Level 1 role)

Experience with medical device testing required

Ability to read and interpret electrical and mechanical schematics

Experience with electrical testing methods

Strong understanding of risk assessment principles

Proficiency in Excel strongly preferred

Experience with multiple device types; ENT device experience a plus (any medical device background considered)

Familiarity with statistics and data analysis

Strong root-cause and problem-solving skills

Effective verbal and written communication skills

Knowledge of Six Sigma / Process Excellence tools a plus

Familiarity with FMEA and Fault Tree Analysis a plus

Understanding of Human Factors and Health Hazard Risk analysis a plus

Knowledge of ISO 13485, FDA Quality System Regulation, and ISO 14971 a plus

Experience with Minitab, QI Macros, or similar quality software a plus

Experience with CAPA, NCR, or audit tracking software a plus

Why This Role

Hands-on lab environment working directly with medical device testing (not a desk-only QA role)

Broad device exposure - great for building a diversified quality engineering background

Direct mentorship and reporting line to the hiring manager

Strong foundation-building role for someone early in their quality/test engineering career

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting or fill out this form to request accommodations.

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Worksite address

irvine, CA, 92713, US

Who can apply

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