Quality Engineer

Insight Global; Gurnee (IL); On-site; USD 90,000 - 125,000; Full time

Job summary

Insight Global in Illinois is seeking a Quality Assurance engineer to lead development, implementation, and continuous improvement of QA processes using data analytics to enhance reporting and operations. The role requires a bachelor's in engineering/quality, 5+ years in quality engineering (medical device manufacturing preferred), ASQ is a plus, and experience with ISO 13485 and risk management.

You will participate in internal and external quality audits and lead process improvement

Qualifications

• Bachelor's degree in engineering, quality or related technical field.
• 5+ years in a quality engineering role, preferably in medical device manufacturing.
• ASQ certification preferred.
• Proficiency in statistical analysis, statistical process control, root cause analysis tools and risk management.
• Strong analytical, leadership and communication skills.
• Experience with ISO 13485.

Responsibilities

• Perform problem identification, resolution, loss reporting and continuous improvement.
• Design and implement methods for process control, process improvement, testing and inspection.
• Develop, execute, and analyze quality reporting measures.
• Participate in internal and external quality audits.

Skills

Statistical analysis

Statistical process control

Root cause analysis

Risk management

Quality reporting

Audits

Leadership

Communication

ISO 13485 experience

Education

Bachelor's degree in engineering, quality or related technical field

Job description

About the Role

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.

Responsibilities

• Perform problem identification, resolution, loss reporting and continuous improvement
• Design and implement methods for process control, process improvement, testing and inspection
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits

Required Skills

• Bachelor's degree in engineering, quality or related technical field
• 5+ years related experience in quality engineering role, preferably in medical device manufacturing
• ASQ certification preferred
• Technical skills: Proficiency in statistical analysis, statistical process control, root cause analysis tools and risk management
• Strong Analytical, leadership and communication skills
• Experience with ISO 13485