Onsite Medical Device QA Test Engineer – Complaints

Intellectt Inc; Irvine (CA); On-site; USD 48,000 - 54,000; Full time

Job summary

Intellectt Inc. is seeking an early-career Quality Test Engineer to support complaint investigations for a medical device environment in Irvine, CA.

The role involves hands-on evaluation and testing of returned devices to determine potential failure causes and support compliant documentation. The position is 100% onsite in Irvine, requires PPE, and emphasizes laboratory-based testing, review of DHRs, and collaboration with Quality, Regulatory, and Manufacturing teams to close investigations and

Qualifications

• Must have a bachelor’s degree in an engineering field (Biomedical, Electrical, Mechanical or related).
• Minimum 2+ years of relevant professional experience in medical device quality/testing.
• Hands-on lab testing experience and electrical testing knowledge.
• Familiarity with FDA medical device quality requirements (e.g., 21 CFR 820.198).

Responsibilities

• Investigate customer complaints by evaluating and testing returned medical devices.
• Carry out electrical and functional testing in a controlled lab environment.
• Review DHRs and quality records to support investigations.
• Apply risk assessment methods to identify root causes and improvements.
• Document nonconformances clearly and communicate findings to teams.
• Support CAPA activities and implement corrective actions.
• Collaborate with Quality, Regulatory, Manufacturing and Engineering teams to close investigations.

Skills

Engineering degree

2+ years experience

Medical device testing

Electrical testing

Laboratory testing

FDA 21 CFR 820.198

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in Biomedical / Electrical / Mechanical engineering

Tools

Microsoft Excel

Job description

Intellectt Inc. is seeking an early-career Quality Test Engineer to support complaint investigations for a medical device environment in Irvine, CA.

The role involves hands-on evaluation and testing of returned devices to determine potential failure causes and support compliant documentation. The position is 100% onsite in Irvine, requires PPE, and emphasizes laboratory-based testing, review of DHRs, and collaboration with Quality, Regulatory, and Manufacturing teams to close investigations and