Reading Metro Area, PA
- Provide Quality Assurance support and guidance on proposed product, process, and document changes.
- Actively participate and contribute in routine platform-based meetings.
- Develop as the subject matter expert for focus areas to support engineering and operations.
- Uses various statistical and non-statistical problem-solving tools as part of analysis
- Assure there are adequate products and process controls in place for identified CTQ s.
- Will initiate and complete GAP analysis against local, global, and industry standards.
- Will continually develop the quality system through GAP analysis results and change control activities. Will lead and facilitate training to further support product and process improvement.
- Uses various statistical and non-statistical problem-solving tools as part of analysis.
- Investigate; provide input and approval on non-conformance incidents (NCI) and Corrective Actions and Preventive Actions (CAPA).
- Will track and trend NCI and CAPA using various statistical and non-statistical problem solving tools.
- Will drive the reduction of reoccurring and non-reoccurring events through MRB and IRB.
- Lead, facilitate, and train others in the execution of risk management processes (risk identification, mitigation, and controls) in compliance with external standards and corporate requirements.
- Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem solving tools as part of analysis.
- Responsible for the intiation and leadership of large capital and/or high risk projects.
- Provide day-to-day mentoring, assistance and support to platform Quality Engineers, Associate Quality Engineers, Quality Operations and Supplier Quality personnel related to transfer, validation and qualification concepts and execution, calibration and PM approval, root cause investigations and investigation tools, general process challenges and troubleshooting on the assigned manufacturing platform floor including event identification and quarantine processes, supplier action request, etc.
Six Sigma Black Belt Certification; Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)
B.S. in Science or Engineering Discipline
M.S. or higher in Physical Science or Engineering