Senior Design Quality Engineer (Medical Devices, NPI)

Intelex Technologies Inc; Irvine (CA); Hybrid; USD 101,000 - 169,000; Full time

Job summary

Advanced Sterilization Products (Fortive) in Irvine, CA seeks a Senior Design Quality Engineer (Consumables) to drive risk management, design control, and verification/validation for life science products. This hybrid role emphasizes QA alignment with FDA QSR 21 CFR 820, ISO13485, and all relevant regulatory requirements.

You will guide NPI and LCM activities, coordinate cross-functional reviews, and lead investigations into nonconformances while supporting audits and continuous improvement

Qualifications

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

Responsibilities

• Owns the Risk Management process across cross-functional teams.
• Performs investigations, NCs and CAPAs with rigorous analysis and closure.
• Supports NPI, design changes, and post-launch activities.
• Provides QMS guidance and training to colleagues.
• Supports audits and regulatory inspections as Quality SME.

Skills

Risk Management

Design Control

Verification & Validation

CAPA

FMEAs

Regulatory knowledge

FDA QSR 21 CFR 820 / ISO13485

Statistical methods

6-Sigma / Lean

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering or related technical field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Advanced Sterilization Products (Fortive) in Irvine, CA seeks a Senior Design Quality Engineer (Consumables) to drive risk management, design control, and verification/validation for life science products. This hybrid role emphasizes QA alignment with FDA QSR 21 CFR 820, ISO13485, and all relevant regulatory requirements.

You will guide NPI and LCM activities, coordinate cross-functional reviews, and lead investigations into nonconformances while supporting audits and continuous improvement