Quality Operations Specialist I

About the role

Located in Irvine, CA, this is a 1‑year contract position (Monday‑Friday, 8 am‑5 pm) offering health and 401k benefits. We are seeking an early‑career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices. This hands‑on role involves troubleshooting products, investigating technical issues, documenting findings, and working with cross‑functional teams. It provides opportunity to work across engineering, manufacturing, and quality functions and to build experience in medical‑device quality, complaint investigation, and product troubleshooting.

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.

Requirements

• Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related engineering/science discipline.
• Approximately 2+ years of professional engineering experience.
• 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.

Qualifications

• Healthcare, medical device, biomedical, biotech, or regulated manufacturing experience is 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, CAP