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Senior Quality Engineer
Ref No.: 18-35511
Location: Madison, Michigan
Position Type:Direct Placement
Experience Level: 7 Years
Start Date: 05/22/2018
 
Primary job duties will include:
 
  • Develop Quality and process cost improvement activities.
  • Reliability, Risk management, Analytics/statistical techniques, Requirements management, Verification & Validation.
  • Design control across the lifecycle of the product.
  • Develop leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
  • Develop review and approvals for the release of product changes ensuring quality requirements are met.
  • Provide leadership & support to process and Quality excellence initiatives including Value Engineering, six-sigma & lean thinking.
  • Direct development & consistent application of quality policies & procedures in product change control, design & development.
  • Develop analytical problem-solving skills and sound statistical application in areas such as DOE, sampling technique, regression, reliability, FMEA, hypothesis testing, etc...
  • Draft and review documentation related to procedures, Special instruction and reports etc...
  • Draft and review documentation related to procedure, special instruction and reports etc...
  • Develop verification and validation strategies for end to end process validation.
  • Project Management
  • Document Management   and Engineering Change
  • Post Market Surveillance activities
  • Other activities as defined by Ethicon & NeuWave Team