Quality Engineer

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 the QE 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.

Essential responsibilities include the following, other duties may be assigned:

• Create and maintain design and process risk analysis (e.g., FMEAs). Work with Operations, Engineering, Supply Chain and Sales 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 Operations, Engineering, Supply Chain and Sales 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.

• Bachelor's degree (B. S.) from four-year college or university in Engineering, Statistics or related field; or four years related experience and/or training; or equivalent combination of education and experience

• Shop floor experience in troubleshooting and resolving daily quality issues.
• Strong analytical skills including the use of simple and complex quality tools.
• Working knowledge to perform and lead kaizens.
• Solid verbal and written communication skills.

• Deep software skills including, MS Office, ERP, and Statistica, Mini Tab, 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).

• 6+ years of experience.
• Visual detection, PLC automation/controls experience and knowledge
• Experience developing and implementing quality systems/processes within existing business units.

• Prolonged periods of sitting at a desk and working on a computer.
• Manufacturing environment.
• Must be able to lift up to 50lbs.
• Various levels of gowning are required.

• Ability to travel (US and internationally)
• Ability to work evenings and/or weekends