Quality Engineer II - Medical Devices – Fremont

General Summary:

This position supports the quality of Boston Scientific's Imaging (IVUS) Medical Devices.

To develop and implement appropriate quality system elements to ensure the high quality level of new and existing products. Works with problems of moderate scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgement and practices to determine appropriate action.


Specific Duties and Responsibilities

• Investigates customer complaints following corporate and site SOP’s and documents into complaint management system.
  
  
• Leads complaint reduction activities.
  
  
• Participates in the development of testing and inspection methodology and documentation for new and existing products.
  
  
• Designs and installs QC process sampling systems, procedures, and statistical techniques
  
  
• Designs or specifies inspection and testing mechanisms and equipment
  
  
• Performs failure analyses and defect investigations
  
  
• Analyzes production limitations and standards
  
  
• Recommends revision of specifications
  
  
• Interfaces with other engineering departments within the company, customers, and suppliers on quality related issues
  
  
• Participates in the development of standard operating procedures.
  
  
• Performs responsibilities required by the Quality System and other duties as assigned or requested.
  
  
  * Indicates Essential Function
  
  Position Qualifications
  
  Minimum education: Bachelor's Degree in Engineering
  
  Minimum experience: 3-5+ years quality engineering experience preferably in a medical devices environment or equivalent combination of eduation and experience required to perform at this level.
  
  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
  
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