Senior Design Quality Engineer – NPI & Risk Management

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

Job summary

Advanced Sterilization Products, Inc. is seeking a Quality Engineer to provide design quality guidance for NPI and Life Cycle Management, focusing on risk management, design control, and verification/validation across life science products.

The role requires strong communication, project planning, and regulatory knowledge to support audits and continuous improvement within a regulated environment.

Qualifications

• Bachelor’s degree in Engineering, Science or technical field; Engineering degree preferred.
• Minimum 4 years in Quality Assurance/Quality Engineering or related field.
• Minimum 3 years in FDA or regulated industry (medical device/pharma/aerospace) or equivalent.

Responsibilities

• Owns Risk Management process and collaborates with cross-functional teams.
• Performs complex investigations including formal NCs and CAPAs; ensures sound analysis and timely closure.
• Leads training and guidance on quality system elements to staff with less experience.
• Supports audits and regulatory inspections and interfaces with regulatory bodies as needed.

Skills

Quality engineering

Risk management

FMEAs

Design control

Statistical methods

Cross-functional communication

Project planning

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Science

Tools

Excel

Word

PowerPoint

Job description

Advanced Sterilization Products, Inc. is seeking a Quality Engineer to provide design quality guidance for NPI and Life Cycle Management, focusing on risk management, design control, and verification/validation across life science products.

The role requires strong communication, project planning, and regulatory knowledge to support audits and continuous improvement within a regulated environment.