Quality Engineer

Global Technical Talent, an Inc. 5000 Company
Waukesha, WI Contractor
POSTED ON 12/13/2024
AVAILABLE BEFORE 2/9/2025
Quality Engineer
  • Contract Duration 4 Months
 
What You’ll Do:
  • As a Quality Engineer II, you will be responsible for ensuring product quality, reliability, and compliance with regulatory requirements throughout the product lifecycle.
  • Leveraging your experience and technical expertise, you will support quality assurance activities, drive process improvements, and contribute to the development and implementation of quality management systems.
 
Job Functions:
  • Quality Engineer will support the development and implementation of quality management systems (QMS), including policies, procedures, standards, and documentation, to ensure compliance with regulatory requirements and industry standards.
  • Participate in product development and design control activities, including risk management, design verification/validation, and change control, to ensure product quality and regulatory compliance.
  • Conduct root cause analysis, failure investigations, and CAPA (Corrective and Preventive Action) activities to address quality issues, non-conformances, and customer complaints.
  • Perform quality engineering activities, including statistical analysis, process capability studies, and design of experiments (DOE), to optimize processes and improve product quality and reliability.
  • Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and customer service, to resolve quality issues, implement corrective actions, and support continuous improvement initiatives.
  • Quality Engineer will lead and participate in internal and external audits, inspections, and regulatory assessments to ensure compliance with quality standards, regulations, and customer requirements.
  • Provide technical support and guidance to manufacturing operations, suppliers, and other stakeholders to ensure adherence to quality standards and specifications.
 
Required Qualifications:
  • Bachelor's degree in Engineering, Science, or a related field.
  • 3-6 years of experience in quality engineering, quality assurance, or a related role, preferably in a regulated industry such as medical devices, pharmaceuticals, or aerospace.
  • Strong knowledge of quality management principles, methodologies, and tools, including statistical process control (SPC), root cause analysis, and risk management.
  • Experience with quality management systems (QMS) and regulatory requirements, such as ISO 13485, FDA QSR, and EU MDR.
  • Proficiency in statistical analysis software (e.g., Minitab) and quality engineering tools and techniques.
  • Excellent problem-solving and analytical skills, with the ability to analyze complex issues, identify root causes, and implement effective solutions.
  • Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
 
Preferred Skills:
 
  • Master's degree in Quality Engineering, Industrial Engineering, or related field.
  • Professional certification in quality engineering or related areas (e.g., ASQ Certified Quality Engineer, Six Sigma Green Belt).
  • Experience with risk management methodologies (e.g., FMEA, Hazard Analysis).
  • Familiarity with validation and verification processes and protocols.
  • Knowledge of Lean Six Sigma methodologies and tools for process improvement.
  • Previous experience with quality management software/systems (e.g., TrackWise, MasterControl).
  • Programming experience
 
Benefits:
  • Medical, Vision, and Dental Insurance Plans
  • 401k Retirement Fund

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Salary : $38 - $45

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