Senior Design Quality Engineer – Medical Devices (Hybrid)

Lumicity; Irvine (CA); Híbrido; USD 125.000 - 155.000; Tempo integral

Resumo da vaga

Lumicity in Irvine, CA is seeking a Senior Quality Engineer, Design Quality (Medical Device) to join the quality team on a hybrid schedule (3 days on site).

You will own risk management, validation planning, and remediation actions for a growing product line, partnering with R&D and manufacturing, while supporting FDA inspections and supplier audits. The role offers a base salary of $125,000–$155,000 with an annual bonus.

Qualificações

• BS in Mechanical, Biomedical, Materials, or Electrical Engineering.
• 5+ years of quality engineering in medical devices/medtech.

Responsabilidades

• Lead design controls activities and DHF ownership.
• Drive risk management under ISO 14971 and FMEAs.
• Own nonconformances and CAPAs from investigation to closure.
• Qualify and audit suppliers and manage remediation actions.
• Plan and approve IQ/OQ/PQ validations and test methods.

Conhecimentos

Design controls

Risk management

CAPA management

Root cause analysis

Supplier qualification

Formação

BS in Mechanical, Biomedical, Materials, or Electrical Engineering

Descrição da vaga

Lumicity in Irvine, CA is seeking a Senior Quality Engineer, Design Quality (Medical Device) to join the quality team on a hybrid schedule (3 days on site).

You will own risk management, validation planning, and remediation actions for a growing product line, partnering with R&D and manufacturing, while supporting FDA inspections and supplier audits. The role offers a base salary of $125,000–$155,000 with an annual bonus.