Quality Operations Specialist I

Motion Recruitment Partners, LLC

Irvine (CA)

On-site

USD 70,000 - 95,000

Part time

5 days ago
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Benefits offered by this job

Health benefits
401k

Job summary

Motion Recruitment Partners, LLC is seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality investigations for medical devices in Irvine, CA. This contract role focuses on hands-on troubleshooting, documenting findings, and cross-functional teamwork across Quality, Manufacturing, and R&D.

The ideal candidate has about 2 years of professional engineering experience, familiarity with regulatory quality requirements, and strong analytical/problem‑solving skills.

Qualifications

  • Bachelor’s degree in Biomedical, Electrical or Mechanical Engineering; related engineering/science degree acceptable.
  • Approximately 2 years of professional engineering experience.
  • Healthcare/medical device or regulated manufacturing experience preferred.
  • Experience with technical troubleshooting, product evaluation, manufacturing issues or quality investigations.

Responsibilities

  • Investigate technical and customer complaints involving medical devices.
  • Troubleshoot hands-on and evaluate customer-returned devices and manufacturing nonconformities.
  • Document investigation results accurately per procedures and timelines.
  • Support manufacturing quality activities, including product/process issues and SAP‑related quality functions.
  • Assist with complaint intake by reviewing and verifying initial complaint information and coding.
  • Monitor and trend customer complaints, service calls, and manufacturing rejections to identify recurring issues.
  • Assist with root‑cause investigations and corrective actions related to product and process issues.
  • Collaborate with Quality, Manufacturing, R&D, Supply Chain and others on product/process improvements.
  • Maintain accurate technical and quality documentation.
  • Follow applicable company quality procedures and medical-device regulatory requirements.

Skills

Troubleshooting
Analytical skills
Written & verbal communication

Education

Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering

Tools

Microsoft Excel
SAP

Job description

Biomedical / Electrical / Mechanical Engineer – Medical Device Quality
Location:

Irvine, CA

Job Type:

Contract with Health and 401k benefits

Duration:

1 year

Schedule

M – F, 8-5

Experience

2 years

We are seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices. This is a hands‑on opportunity for an engineer who enjoys troubleshooting products, investigating technical issues, documenting findings, and working with cross‑functional teams.

Responsibilities
  • Investigate assigned technical and customer complaints involving medical devices.
  • Perform hands‑on troubleshooting and evaluation of customer-returned devices and manufacturing nonconformities.
  • Document investigation results accurately and in accordance with established procedures and timelines.
  • Support manufacturing quality activities, including product/process issues and SAP‑related quality functions.
  • Assist with complaint intake by reviewing and verifying initial complaint information and coding.
  • Monitor and trend customer complaints, service calls, and manufacturing rejections to identify recurring issues.
  • Assist with root‑cause investigations and corrective actions related to product and process issues.
  • Collaborate with Quality, Manufacturing, R&D, Supply Chain, and other teams on product and process improvements.
  • Maintain accurate technical and quality documentation.
  • Follow applicable company quality procedures and medical‑device regulatory requirements.
Qualifications
  • Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related engineering/science discipline.
  • Approximately 2 years of professional engineering experience.
  • Healthcare, medical device, biomedical, biotech, or regulated manufacturing experience is preferred.
  • Experience with technical troubleshooting, product evaluation, manufacturing issues, or quality investigations.
  • Strong analytical, problem‑solving, written, and verbal communication skills.
  • Strong computer skills, including Microsoft Excel.
  • Ability to review technical information, investigate problems, and clearly document findings.
Preferred
  • Experience with medical‑device complaints or quality records.
  • Familiarity with FDA regulations, ISO 13485, or other medical‑device quality requirements.
  • Exposure to FDA MDRs, Vigilance reporting, CAPA, nonconformances, or post‑market surveillance.
  • Experience working with SAP or other ERP/quality systems.
  • Experience troubleshooting electrical, mechanical, or electromechanical devices.
Why Consider This Opportunity
  • Hands‑on engineering experience within a medical‑device environment.
  • Opportunity to work across engineering, manufacturing, and quality functions.
  • Good fit for an engineer looking to build experience in medical‑device quality, complaint investigation, and product troubleshooting.
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