Principal Product Complaint Analyst

Boston ScientificGeorgetown, MA
6d

About The Position

Your responsibilities will include: Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes Applying systems-thinking of a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement Working independently across the organization

Requirements

  • Bachelor's degree, preferably in a scientific, engineering, or technical discipline
  • Minimum of 8+ years of medical device industry experience
  • Demonstrated ability to understand, shift and contribute to changing priorities
  • Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.)
  • Working knowledge and practical implementation of FDA, ISO, MDR regulations within the medical device industry
  • Demonstrated proficiency in project management
  • Travel approximately <5% of the time
  • Non-conformance and Corrective Action Preventative Action (CAPA) experience
  • Strong research, communication and presentation skills
  • Effective written and oral communication, technical writing, and editing skills
  • Ability to work independently with minimal direction or supervision
  • SAS, Snowflake or similar querying/analytic software experience

Responsibilities

  • Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes
  • Applying systems-thinking of a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement
  • Working independently across the organization
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