Systems Quality Engineer - Design & Validation Lead

Lancesoft; Bothell (WA); Hybrid; USD 76,000 - 81,000; Full time

Job summary

Lancesoft seeks a Systems Design Quality Engineer in Bothell, WA, on a hybrid arrangement. The role focuses on design control, validation, and risk management to ensure compliant, high-quality products.

Projects span hardware, software, and systems with extensive documentation and audits. The position requires experience with CAPA, regulatory standards, and continuous improvement to uphold safety and product reliability.

Qualifications

• Experience applying design control processes across hardware, software, and systems.
• Experience leading CAPA and root cause analysis to improve product quality.
• Familiarity with regulatory requirements and quality audits.

Responsibilities

• Lead design control from inputs through transfer to production.
• Manage verification, validation, and design transfer with rigorous documentation.
• Oversee CAPA, risk management, and continuous improvement activities.

Skills

Design Quality Management

Data Analysis & Interpretation

Design for Quality

Root Cause Analysis

CAPA Methodologies

Regulatory Requirements

Privacy, Safety, and Security

Risk Assessment

Technical Documentation

Continuous Improvement

Product Quality and Reliability

Defect Management

Design Verification Planning

Design Validation Planning

Product Test Design

Job description

Lancesoft seeks a Systems Design Quality Engineer in Bothell, WA, on a hybrid arrangement. The role focuses on design control, validation, and risk management to ensure compliant, high-quality products.

Projects span hardware, software, and systems with extensive documentation and audits. The position requires experience with CAPA, regulatory standards, and continuous improvement to uphold safety and product reliability.