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Engineering
Validation Engineer
Feasterville-Trevose, PA
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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 Apply Now
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