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:

Primary Responsibilities / Essential Functions

· 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.

Basic Qualifications

Education

· 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

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.

Preferred Qualifications

· Deep software skills including, MS 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).

Sr. Quality Engineer -

· 6+ years of experience.

· Visual detection, PLC automation/controls experience and knowledge

· Experience developing and implementing quality systems/processes within existing business units.

Working Conditions

· 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.

Special Requirements

· Ability to travel (US and internationally)

· Ability to work evenings and/or weekends