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