Senior Design Quality Engineer, Consumables

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

Benefits offered by this job

Bonus or Equity

Job summary

Advanced Sterilization Products is seeking a Senior Design Quality Engineer to provide QA guidance for NPI and lifecycle activities in Irvine. The role focuses on design control, risk management, and verification/validation across electro-mechanical devices and sterilization products.

You will influence CAPA decisions and support audits while collaborating with cross-functional teams to meet regulatory requirements.

Qualifications

• Bachelor’s Degree in Engineering, Science (Biology, Microbiology, Chemistry, etc.) or other technical field.

Responsibilities

• Owns the Risk Management process and facilitates risk analyses and design control processes.
• Performs complex technical investigations including NCs and CAPAs and coordinates cross-functionally.
• Provides training on quality management system elements to colleagues and partners.
• Supports and participates in cross-functional projects and may lead small projects with manageable risks.

Skills

Quality engineering

Risk Management

Design Control

FMEA

Root Cause

Verification and Validation

Regulatory knowledge

Excel

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Advanced Sterilization Products is seeking a Senior Design Quality Engineer to provide QA guidance for NPI and lifecycle activities in Irvine. The role focuses on design control, risk management, and verification/validation across electro-mechanical devices and sterilization products.

You will influence CAPA decisions and support audits while collaborating with cross-functional teams to meet regulatory requirements.