Senior Design Quality Engineer – NPI & Risk

Advanced Sterilization Products, Inc.; Irvine (CA); On-site; USD 101,000 - 169,000; Full time

Job summary

Advanced Sterilization Products, Fortive family, seeks a senior Quality Engineer to lead risk management, design control, and verification/validation across new product introductions and lifecycle management. You will investigate complex issues, coordinate cross-functional teams, and ensure compliance with FDA QSR 21 CFR 820 and ISO 13485.

The role includes audits support and process improvements. The ideal candidate has 4+ years in quality engineering within regulated industries, strong

Qualifications

• Bachelor's degree in engineering, science or related technical field.
• Experience in quality assurance/engineering within FDA or regulated environments (medical devices, pharma, aerospace) preferred.
• Strong knowledge of quality systems and regulatory requirements (FDA QSR 21 CFR 820, ISO 13485).

Responsibilities

• Owns and improves Risk Management and design control processes.
• Manages complex investigations (NCs, CAPAs) and cross-functional coordination to ensure robust verification/validation.
• Supports audits and regulatory readiness with quality system expertise.
• Provides guidance and training on quality management system elements to teammates.
• Leads small projects with manageable risk and resource needs.
• Applies Six Sigma/Lean and statistical methods to improve products and processes.

Skills

Quality engineering

Risk Management

Design Control

Verification & Validation

CAPA

FMEA

Regulatory compliance

Cross-functional collaboration

Statistical methods

Project management

Communication

Education

Bachelor's Degree in Engineering/Science/related field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Statistical software

Job description

Advanced Sterilization Products, Fortive family, seeks a senior Quality Engineer to lead risk management, design control, and verification/validation across new product introductions and lifecycle management. You will investigate complex issues, coordinate cross-functional teams, and ensure compliance with FDA QSR 21 CFR 820 and ISO 13485.

The role includes audits support and process improvements. The ideal candidate has 4+ years in quality engineering within regulated industries, strong