Product Analyst II - Medical Device Complaints – Fremont

Product Analyst II, will be responsible for performing the domestic and international product surveillance activities for all medical devices, manufactured, marketed, distributed and serviced by the Boston Scientific (BSC) and managed by Fremont Complaint Management Center.. Primary responsibility for all administrative activities associated with the complaint handling program including, but not limited to, reviewing, managing and closing complaints records in the complaint handling system. This individual will evaluate product complaints related to the quality, reliability, safety, and effectiveness of all BSC products managed by the Fremont Complaint Management Center (CMC). Supports the continuous improvement effort of the BSC quality system for processing complaints in order to meet FDA, ISO and international regulatory requirements.

• Receives and queries Global Complaint Database (GCS2) System for related complaints. *
  
• Communicates with Clinicians, Sales and Marketing teams and other internal or external customers to identify details related to complaint information and occurrence. *
  
• Determines reportability of complaints and submits applicable regulatory reports to the FDA.
  
• Interacts with investigator(s) to ensure investigation is completed in a timely manner.*
  
• Perform Good-Faith –Effort to return product for investigation and obtain required information for complaint assessment.
  
• Reviews investigation reports to ensure analysis is appropriate and complete.*
  
• Reviews associated complaint records to ensure the applicable assessment, regulatory, and investigation records are created and completed.*
  
• Ensures customer complaint response letters are completed in a timely and comprehensive manner.*
  
• Understand team performance metrics and drive for achieving the goals.*
  
• Perform Ad hoc reporting and researching.*
  
• Contributes to process improvement activities and projects related to the complaint program.*
  
  * Indicates Essential Function
  
  Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
  
  Qualifications
  
  Minimum Education:
  
  
• A college degree in Biology, Life Science or similar degree, or equivalent combination of education and experience.
  
  Minimum Experience and Skills:
  
  
• 2-4 years of experience in post market surveillance and handling of complaints for medical devices.
  
• Experience in FDA Medical Device Reporting is also required.
  
  Working Conditions
  
  Primarily office environment including possible laboratory environment with some risk of exposure to biohazards, including bloodborne pathogens.
  
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