Medical Device Quality Engineer: Troubleshooting & CAPA

Motion Recruitment; Irvine (CA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

401k

Job summary

Motion Recruitment is seeking a Biomedical/Regulatory Quality Engineer to investigate technical customer complaints and manufacturing nonconformities for medical devices through hands-on troubleshooting. The engineer will document findings, monitor complaint trends, and collaborate with cross-functional teams to implement corrective actions and process improvements.

A Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering is strongly preferred, with at least one year of

Qualifications

• Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering with at least 1 year of professional experience.
• Experience in regulated manufacturing with FDA regulations and ISO 13485 strongly preferred.
• Experience in medical device quality, CAPA, and complaint handling is desirable.

Responsibilities

• Investigate technical customer complaints and manufacturing nonconformities.
• Document findings and monitor complaint trends.
• Collaborate with cross-functional teams to implement corrective actions.
• Drive process improvements and CAPA effectiveness.

Skills

Technical Troubleshooting

Product Evaluation

Root Cause Analysis

Quality Investigations

Complaint Handling

Medical Device Quality

CAPA

Post-market Surveillance

Analytical Skills

Cross-functional Collaboration

Education

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

Tools

SAP

Microsoft Excel

ISO 13485

FDA Regulations

Job description

Motion Recruitment is seeking a Biomedical/Regulatory Quality Engineer to investigate technical customer complaints and manufacturing nonconformities for medical devices through hands-on troubleshooting. The engineer will document findings, monitor complaint trends, and collaborate with cross-functional teams to implement corrective actions and process improvements.

A Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering is strongly preferred, with at least one year of