Senior Design Quality Engineer - Medical Devices (NPI/LCM)

Industrial Scientific Corporation; Irvine (CA); Hybrid; USD 101,000 - 169,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Advanced Sterilization Products, part of Fortive, is seeking a Sr Design Quality Engineer (Mechanical/Electrical) in Irvine, CA. The role leads risk management, design control, and verification/validation activities for NPI and lifecycle programs, ensuring compliance with QMS and regulatory standards across life-science products.

You will work on CAPAs, complex investigations, and cross-functional quality improvements, while mentoring colleagues and supporting audits and regulatory interactions.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum 4 years in Quality Assurance/Quality Engineering in regulated industry.
• Strong knowledge of risk management, design control and verification/validation.
• Experience with NCs/CAPAs and audits is desirable.

Responsibilities

• Owns the Risk Management process and maintains design risk analyses.
• Investigates complex quality issues, documents NCs/CAPAs, and drives timely closures.
• Supports NPI and lifecycle activities with design control and validation.
• Provides training and guidance on QMS elements to teams with less experience.
• Contributes to continuous improvement of quality systems and processes.

Skills

Risk Management

Design Control

Verification & Validation

CAPA

Quality Assurance

FDA QSR 21 CFR 820

Education

Bachelor’s Degree in Engineering

Tools

Excel

Word

PowerPoint

Job description

Advanced Sterilization Products, part of Fortive, is seeking a Sr Design Quality Engineer (Mechanical/Electrical) in Irvine, CA. The role leads risk management, design control, and verification/validation activities for NPI and lifecycle programs, ensuring compliance with QMS and regulatory standards across life-science products.

You will work on CAPAs, complex investigations, and cross-functional quality improvements, while mentoring colleagues and supporting audits and regulatory interactions.