Systems Design Quality Engineer
LancesoftBothell, WA
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Overview
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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.
- 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
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FAQs About Systems Design Quality Engineer Jobs at Lancesoft
What is the work location for this position at Lancesoft?
This job at Lancesoft is located in Bothell, WA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Lancesoft?
Candidates can expect a pay range of $55.
What employment applies to this position at Lancesoft?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Lancesoft?
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