Senior Quality Engineer

Lumicity; Irvine (CA); Hybrid; USD 125,000 - 155,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

Design controls

Risk management

CAPA management

Root cause analysis

Supplier qualification

Education

BS in Mechanical, Biomedical, Materials, or Electrical Engineering

Job description

Senior Quality Engineer, Design Quality (Medical Device)

Irvine, CA | Hybrid, 3 days on site | $125,000-$155,000 base plus annual bonus

About the role:

Join the quality team of a Class II/III device company as the quality partner to research and development and manufacturing. You will own risk management, validation and remedial actions for a growing product line.

What you'll do

• Act as the quality lead on design controls: Assess requisites, verification and validation protocols, and the Design History File (DHF).
• Lead risk management under ISO 14971, including design and process FMEAs.
• Own nonconformances and CAPAs from investigation to closure, using root cause tools (5 Why, 8D).
• Qualify and audit suppliers, and manage supplier remedial actions.
• Plan and approve process validations (IQ/OQ/PQ) and test method validations.
• Support internal audits, FDA inspections and notified body audits, and keep process aligned with the QMSR.

What you'll bring

• BS in Mechanical, Biomedical, Materials, Electrical or a related engineering field.
• 5+ years of quality engineering in a medical device or medtech company.