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Lean/Six Sigma Green or Black Belt Certification is a plus. Knowledge in Organizational Excellence and Lean/Six Sigma. Lean/Six Sigma Green or Black Belt Certification is a plus. FDA, Notified Body (BSI) and Corporate, among others.
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Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
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Research and test design ideas to determine feasibility, utilizing lean manufacturing, kaizen, Six Sigma, and root cause analysis to formulate and support innovation, corrective actions, and improvements.
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Technical training and experience using Statistics, Lean, and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and/or other improvement tools and programs.
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MANDATORY SKILLS - product manufacturing quality in casting/ injection molding/ machining. Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day support.
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Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Experience working in both an FDA and European regulatory environment is required.
$90,000 a yearFull-timeExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) certification is a plus. Work with CPS Purchasing in the monitoring & reporting of external provider quality and on-time delivery performance.
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