Job: Post Market Complaint Specialist – Japan

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Title Post Market Complaint Specialist – Japan
Salary $100-$150K plus bonus
Location MA
Job Information

Our client is a global manufacturer of medical devices in Boston, MA.  They are looking for a Bilingual Sennior Post Market Complaint Specialist – Japan.

Principle Duties and Responsibilities:

  • Facilitates the timely completion of medical device customer complaint investigations.
  • Ensures compliance to U.S. and international medical device complaint reporting requirements, with particular focus on Japan.
  • Report and analyze data using quality tools such as Paretos, histograms, and rate calculations.
  • Works closely with engineering investigation teams to assure the timely closure of technical investigations.
  • Interacts with cross-functional teams to obtain information pertinent to the complaint investigation.
  • Writes customer letters.

Requirements:

  • Bachelor’s Degree with 5 years complaints experience; Medical device experience preferred
  • Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus
  • Excellent verbal and written communication skills
  • Familiar with U.S. 21 CFR 803, Canada SOR/98-282, EU MEDDEV and specifically Japan complaint reporting regulatory requirements.
  • Proficient with MS office tools, specifically Excel.
  • Familiar with statistical quality tools.
  • Excellent analytical and problem solving skills.
  • Results oriented and a positive “can-do” attitude.
  • Must be able to multi-task and prioritize daily activities and find perfect balance between day to day tasks and projects.
  • Ability to execute detail-oriented  tasks in a timely manner with high quality and minimal direct supervision
  • Bilingual (Japanese- English) strongly preferred

 

 

 

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