Quality Operations Specialist I

Kelly Services; Irvine (CA); On-site; USD 48,000 - 56,000; Part time

Benefits offered by this job

Health benefits

401(k) benefits

Job summary

Kelly Services is seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality investigations for medical devices in Irvine. This contract role emphasizes hands-on troubleshooting, documenting findings, and cross-functional collaboration to improve product quality.

The ideal candidate has a Bachelor's in biomedical/electrical/mechanical engineering and about 2+ years of professional experience in healthcare or regulated manufacturing, with strong Excel skills and

Qualifications

• Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering or related field.
• 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.
• Strong analytical, problem-solving, and written/verbal communication skills.
• Proficiency with Microsoft Excel.

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 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 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, and Supply Chain teams on improvements.
• Maintain accurate technical and quality documentation.
• Follow applicable company quality procedures and medical-device regulatory requirements.

Skills

Analytical thinking

Problem solving

Written communication

Verbal communication

Education

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

Tools

Microsoft Excel

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.