Quality Operations Specialist I

About the job

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.