Senior Design Quality Engineer - Mech & Electrical (NPI)

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

Job summary

Advanced Sterilization Products in Irvine, CA is hiring a Sr Design Quality Engineer (Mechanical/Electrical). You will lead Risk Management, drive CAPAs, and support Design Verification and Validation across NPI and lifecycle activities.

You will mentor peers, advise on QMS improvements, and ensure regulatory compliance with FDA QSR and ISO13485. The role requires strong communication, project leadership, and cross-functional collaboration with Operations, R&D, and Suppliers.

Qualifications

• Bachelor’s degree in engineering, science, or technical field.
• 4+ years in Quality Assurance/Quality Engineering.
• 3+ years in FDA or other regulated industries (medical device, pharma, aerospace).

Responsibilities

• Owns and guides Risk Management, collaborates to facilitate risk analyses and design control processes.
• Conducts complex investigations including NCs and CAPAs with cross-functional teams.
• Supports design verification/validation, post-launch activities, and design changes.
• Provides training on QMS elements to colleagues with less experience.
• Leads small projects with manageable risk and resources.

Skills

Quality Engineering

Risk Management

Design Control

Verification & Validation

CAPA

Regulatory Knowledge

Education

Bachelor’s Degree in Engineering, Science, or other technical field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Advanced Sterilization Products in Irvine, CA is hiring a Sr Design Quality Engineer (Mechanical/Electrical). You will lead Risk Management, drive CAPAs, and support Design Verification and Validation across NPI and lifecycle activities.

You will mentor peers, advise on QMS improvements, and ensure regulatory compliance with FDA QSR and ISO13485. The role requires strong communication, project leadership, and cross-functional collaboration with Operations, R&D, and Suppliers.