Quality Operations Specialist I

Motion Recruitment Partners LLC

Irvine, Northern (CA, KY)

Hybrid

USD 70,000 - 110,000

Part time

7 days ago
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Job summary

Motion Recruitment Partners LLC is seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices in Irvine, CA. This contract role lasts 1 year, with a Monday–Friday, 8–5 schedule and an expectation of 2+ years of professional engineering experience.

You will investigate complaints, perform hands-on troubleshooting, document findings, and collaborate with Quality, Manufacturing, R&D, and other teams to drive product and

Qualifications

  • Bachelor's degree in Biomedical Engineering, Electrical Engineering, or Mechanical Engineering.
  • 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 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.
  • Collaborate with Quality, Manufacturing, R&D, and other teams on product and process improvements.
  • Maintain accurate technical and quality documentation.

Skills

Hands-on troubleshooting
Analytical problem-solving
Written/verbal communication

Education

Bachelor's degree in Biomedical Engineering, Electrical Engineering, or Mechanical Engineering

Tools

Microsoft Excel

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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