Systems Design Quality Engineer

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

Job Title: Systems Design Quality Engineer Location: Bothell, WA (Hybrid) Duration: 12+ months (Possible Extension) Pay rate: $55/hr. –$59.00/hr. On w2 (All Inclusive)

Job Description: Creates and executes comprehensive process validation strategies using statistical tools to ensure the seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision. Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements. Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence. Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements. Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality. Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards. Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and the implementation of solutions to prevent recurrence and drive continuous improvement. Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.

Preferred Skills:

• Design Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• 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