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Systems Design Quality Engineer
LanceSoft Inc
- 🇺🇸 United States
- On-site
- 2 weeks ago
- $55.00 – $59.80 / hour
- Risk Management
- CAPA
2 weeks ago
Not enough detail in this posting to match
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
Systems Design Quality Engineer · LanceSoft Inc