Quality Engineer

Position Summary

The Quality Engineer is responsible for leading projects to continuously improve the quality of our products and processes. Working as a project leader and internal consultant, works closely with department managers and team leaders to define improvement targets, measure and analyze process capabilities, perform root-cause analysis projects, implement improvements and control ongoing performance. Responsible for the quality system, customer concern processing and supporting development/ production processes.

Primary Responsibilities

• Create and maintain design and process risk analysis (e.g., FMEAs). Work with Manufacturing, Engineering, Supply Chain and Sales departments on risk mitigation activities.
• Identify and report quality related trends and develop processes/ systems to detect those trends proactively and respond accordingly to improve product and process quality.
• Lead the implementation of standard quality systems/ processes for the detection, control, and remediation of production quality issues.
• Initiate capital investment requests or other strategic activities to improve product and process quality.
• Works with Manufacturing, Engineering, Supply Chain and Sales departments to coordinate and lead cross functional efforts to address quality concerns or drive improvement in current performance.
• Works directly with customers on quality concerns including response to issues and conflict resolution.
• Teach and coach best practices in problem solving, root cause analysis, statistical quality control, and authoring work instructions.
• Participate in internal audit system and provide assistance to teams in resolving corrective actions.
• Support quality improvement projects as deemed necessary by the organization.
  
  

Preferred Qualifications

Education

• Bachelor's Degree in Engineering, Statistics or related field.
  
  

Experience

• Minimum 3 to 5 years’ experience in closely related function.
  
  

Other Requirements

• Deep software skills including Microsoft Office, ERP, and Statistica, MiniTab, or related statistical analysis tool.
• Background in Total Quality Management (TQM), FDA Good Manufacturing Practices (GMP), and ISO 9000 concepts.
• Certification or specialized training in Statistical Process Control (SPC) and Design of Experiments (DOE).
• Shop floor experience in troubleshooting and resolving daily quality issues.
• Strong analytical skills including the use of simple and complex quality tools.
• Visual detection, Programmable Logic Controllers (PLC) automation/ controls experience and knowledge.
• Experience developing and implementing quality systems/ processes within existing business units.
• Working knowledge to perform and lead kaizens.
• Solid verbal and written communication skills.