Job Description
| Role | Product Quality Engineer |
| Location | Bothell, WA (Hybrid) |
| Duration | 24+ months (Possible chances of conversion) |
| Shift | Monday – Friday |
| Pay Range | $45-$59/hr. on W2 |
Job Responsibilities:
- 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.
- Ensures the success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
- 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.
- Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
- 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.
- Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones.
- Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
- Minimum required Experience: Minimum 5+ years of experience with a Bachelor's degree in areas such as Quality Engineering, Safety Engineering, R&D Engineering, or equivalent OR no prior experience required with a Master's Degree.
- Preferred Certification: Six Sigma Green Belt
- 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
Numbers & Facts
| Location | Bothell, WA |
| Industry | Staffing/Employment Agencies |
| Salary | $59.84 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Bug Tracking/Defect Managementunmatched
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Data Analysisunmatched
- Design Verificationunmatched
- Documentationunmatched
- Electronic Engineeringunmatched
- Identify Issuesunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Mechanical Engineeringunmatched
- Mentoringunmatched
- People Managementunmatched
- Performance Analysisunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Product Designunmatched
- Product Engineeringunmatched
- Product Lifecycleunmatched
- Product Safetyunmatched
- Product Testingunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Records Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Research & Development (R&D)unmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Safety Engineeringunmatched
- Six Sigma Certificationunmatched
- Six Sigma Green Beltunmatched
- Surveillanceunmatched
- Systems Analysisunmatched
- Technical Writingunmatched
- Test Designunmatched
- Usability Engineeringunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Verification Plansunmatched
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