Medical Device Quality Engineer: Troubleshooting & CAPA

Motion Recruitment; Irvine (CA); Presencial; USD 85.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

401k

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Technical Troubleshooting

Product Evaluation

Root Cause Analysis

Quality Investigations

Complaint Handling

Medical Device Quality

CAPA

Post-market Surveillance

Analytical Skills

Cross-functional Collaboration

Educación

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

Herramientas

SAP

Microsoft Excel

ISO 13485

FDA Regulations

Descripción del empleo

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