Systems Design Quality Engineer

Job Title: Systems Design Quality EngineerLocation: Bothell, Washington — HybridEmployment Type: ContractDuration: 12 MonthsJob Summary: We are seeking a Systems Design Quality Engineer to support product quality, design controls, process validation, risk management, and continuous improvement throughout the product lifecycle. The ideal candidate will have experience in Quality Engineering, Safety Engineering, R&D Engineering, or a related field, with strong knowledge of regulatory requirements, CAPA, root cause analysis, design verification and validation, and quality management practices.Responsibilities:Create and execute comprehensive process validation strategies using statistical tools to support the seamless transition of new products to production while meeting quality and regulatory standards.Manage the design control process, including design inputs, verification, validation, and design transfer, ensuring adherence to regulatory and quality standards.Develop and maintain quality engineering documentation, including quality plans for hardware, software, and systems.Support quality improvement initiatives by integrating quality, reliability, and Post Market Surveillance (PMS) insights throughout the product lifecycle.Assess product and system designs, review performance data, and conduct root cause analysis to identify and address quality deficiencies.Validate critical design inputs related to usability, reliability, performance, manufacturability, and safety.Guide risk management activities throughout the product lifecycle by identifying, assessing, and mitigating potential risks.Analyze post-market performance data and provide actionable feedback to manufacturing and design teams.Support corrective actions based on field performance and product quality findings.Prepare for quality audits and inspections by maintaining appropriate documentation and ensuring compliance with internal and external quality standards.Manage and execute CAPA activities, including problem identification, root cause analysis, corrective actions, and preventive measures.Apply continuous improvement techniques to strengthen quality practices and maintain audit readiness.Collaborate with internal and external stakeholders and provide guidance to ensure alignment with quality standards and project milestones.Required Qualifications:Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.With a Bachelor's degree, a minimum of 5+ years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or an equivalent area.Candidates with a Master's degree may be considered with no prior experience requirement.Strong understanding of quality engineering and design quality principles.Experience with data analysis and interpretation.Knowledge of root cause analysis and CAPA methodologies.Understanding of regulatory requirements and risk assessment.Experience with technical documentation and quality processes.Preferred Qualifications:Six Sigma Green Belt certification.Experience with Design for Quality (DFQ).Knowledge of privacy, safety, and security considerations.Experience with product quality and reliability.Experience with defect management.Knowledge of design verification planning and design validation planning.Experience with product test design.Experience applying continuous improvement methodologies.Work Requirements:Hybrid work arrangement in Bothell, Washington.Ability to collaborate effectively with cross-functional and external stakeholders.Ability to work with limited supervision while managing quality activities throughout the product lifecycle.Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements. Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.Application: Interested candidates are encouraged to apply with an updated resume highlighting relevant Systems Quality Engineering, Design Quality, Design Controls, Risk Management, CAPA, Validation, and Regulatory experience.