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Experience with flying probe test systems and DFT- Knowledge of quality tools such as Lean principles, Six Sigma, root cause analysis and corrective action, advanced product quality planning (APQP), metrology, process failure mode and effects analysis (PFMEA), control plans, and various problem-solving approaches.
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Gain hands on experience in Quality Assurances processes including: root cause analysis using typical Lean Six Sigma methodology PFMEA/DFMEA/Control Plan review with suppliers SPC, CAPA.
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3D Drafting in Catia V5 & Fusion 360. Hands on experience using Zeiss 3D Scanning tools & Metrology Software (GomInspect Pro) Gain hands on experience in Quality Control processes and implementation including: Day to Day QC activities (Quality gates, measurements, data acquisition) QC Gate setup & dynamic checklist management processes & tools Assist in the design & implementation of data collection plans, including consideration of how the data will be collected, e.g. check sheets, data coding techniques and automated data collection.
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General experience in Patient Safety Activity(ies) such as RCA, FMEA, Peer Review, Rapid Cycle PDSA, Performance Improvement Methodologies and tools (Six Sigma, Lean, etc.) The Patient Safety, Advocacy and Risk Management Specialist will have responsibility for data entry into the Midas Event Reporting system, the Pennsylvania Patient Safety Reporting System (PA PSRS) including external reporting to PA PSRS and the PA DOH, and running reports and performing data analysis from each of these data bases.
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The ideal candidate is a passionate teacher of Lean & Six Sigma (LSS) leadership, has a proven ability to positively influence a culture of continuous process improvement (CPI), and most importantly, has a proven track record of successfully implementing sustainable improvements that realize measurable business value.
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Prior knowledge and experience working in SAP Ariba Lean Six Sigma Green Belt or similar certification Experience negotiating and developing supplier relationship on Equipment Repair & Maintenance, Welding, Fabrication & Machining and general MRO categories.
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Possess continuous improvement experience with emphasis in the laboratory information management and deployment of LEAN/Six Sigma, analytical methods and manufacturing process development for polymeric materials.
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Analysis of silicone raw materials, intermediate formulation mixes and final formulations using various state-of-the-art analytical techniques including but not limited to GPC, HPLC, GC, rheometer, UV-vis and others.
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Licenses, Certificates or Registration: PMP or CAPM or Lean Six Sigma Green Belt Additional Information: The PMI works with moderate supervision, exercising appropriate judgment & operational considerations.
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Expertise in the conception, formulation, optimization, automation, processing, characterization and manufacture of a unique silicone polymer composition of a specialty medical device including analytical chemical testing including gas and liquid chromatography, gel permeation chromatography (SEC), UV/Vis, FTIR, viscosity testing.
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Utilize extensive knowledge of polymer chemistry principles for materials selection/management, formulation processes to enhance the scalability and quality of the lens material. Background in organic-polymer synthesis and characterization, biocompatible polymers, peptides and lipid-protein-conjugates, oligonucleotides, structure-property relationships, formulation and process development, small & large molecules, analytical separations, isolation and identification of impurities.
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Be hands-on and responsible for providing technical leadership and direction for scaling up and tech-transfer including interaction with external vendors. Hands-on Ph. D. chemist with 10+ years proven industry experience in identification, development and commercialization of innovative market driven technologies including pharmaceuticals and medical devices.
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Credentials / Required Skills:+ Hands-on Ph. D. chemist with 10+ years proven industry experience in identification, development and commercialization of innovative market driven technologies including pharmaceuticals and medical devices.
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Serve as the technical lead and core team member on projects and interact with global clinical, manufacturing, production, quality, regulatory, project management, legal, claims and strategy and marketing personnel.
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Develop and manage world-wide supplier relationship, sourcing and supply chain for Research & Development projects and commercialization of the finished products. Extensive experience working in a GLP laboratory / facility environment.
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