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Kelly Services

Quality Operations Specialist I

Career Insights for Scheduler / Operations Coordinator

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What they do

A Scheduler or Operations Coordinator provides scheduling and logistical support for an office, company or organization. May specialize in scheduling required for production or for administrative work.

$62,913 / year median in California

+4% projected growth

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Job Description

$35.27
  • $40.82
  • 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
•.Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy. Applicants need to make their needs known in advance.

Benefits

  • 401(k) Plans
  • Dental Insurance