Quality Engineer

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

Job Title: Quality Test Engineer (Complaint Investigations)

Employment Type: W2 Contract

Duration: 3+ Months

Salary/Rate: $35–$39 per hour on W2.

The anticipated pay range for this position is $35–$39 per hour. Actual compensation may vary based on factors permitted by applicable law, including relevant experience, qualifications, skills, and business needs.

Benefits: No employer-provided benefits for this contract position.

Job Summary

We are seeking an early-career Quality Test Engineer to support complaint investigations for a medical device manufacturing environment in Irvine, California. This position involves hands‑on evaluation and testing of returned medical devices to help determine potential failure causes and support accurate, compliant complaint documentation.

The role is primarily laboratory-based and requires regular hands‑on testing of returned devices. The position is 100% onsite and may require the use of gloves and other appropriate personal protective equipment (PPE). No cleanroom work is expected.

Responsibilities

• Investigate customer complaints by evaluating and testing returned medical devices.
• Perform electrical testing, functional testing, and product evaluations in a laboratory environment.
• Review Device History Records (DHRs) and other applicable quality records to support complaint investigations.
• Apply appropriate risk assessment methods to assist with root cause determination.
• Identify, document, and communicate product nonconformances accurately and completely.
• Support CAPA activities, including investigation, documentation, follow‑up, and implementation of applicable corrective actions.
• Collaborate with Quality, Regulatory, Manufacturing, Engineering, and other cross‑functional teams to progress complaint investigations through closure.
• Maintain complete and accurate complaint investigation records in accordance with company procedures and applicable regulatory requirements.
• Follow established laboratory, safety, quality, and documentation procedures.
• Escalate potential product, safety, regulatory, or quality concerns through established processes.

Required Qualifications

• Bachelor's degree in an engineering discipline, such as Biomedical, Electrical, Mechanical, or a related field.
• 2+ years of relevant professional experience.
• Experience with medical device complaint investigations.
• Hands‑on laboratory testing and electrical testing experience.
• Working knowledge of FDA requirements applicable to medical device complaint files, including 21 CFR 820.198, as applicable to the position.
• Familiarity with risk assessment and root cause investigation methodologies.
• Ability to interpret technical documentation, test results, and quality records.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross‑functional environment.
• Ability to work 100% onsite in Irvine, California.

Preferred Qualifications

• Experience with ENT devices or capital equipment.
• Proficiency with Microsoft Excel and other standard documentation tools.
• Six Sigma training or certification.
• Experience with Failure Mode and Effects Analysis (FMEA).Experience supporting CAPA or other quality‑system investigations.

Work Requirements

• This is a 100% onsite position in Irvine, California.
• Regular hands‑on laboratory and electrical testing of returned devices is required.
• Appropriate gloves and PPE must be worn when required by established laboratory and safety procedures.
• No cleanroom work is expected for this position.
• Must be able to follow applicable laboratory, workplace safety, quality‑system, and documentation procedures.
• Employment is subject to applicable U.S. federal, California state, and local requirements.

Equal Opportunity Employer

We are an Equal Opportunity Employer. Employment decisions are made without regard to legally protected characteristics under applicable federal, state, and local laws. Reasonable accommodations may be available to qualified individuals with disabilities and for other legally protected needs, consistent with applicable law.