Insulet Corporation

Post Market Surveillance Associate

Job Locations US-MA-Billerica | US-MA-Billerica
Posted Date 1 month ago(1/18/2018 9:45 AM)
Category
Quality Assurance / Quality Engineering

Position Summary

This position is integral to supporting the department through data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints.  It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.

 

Responsibilities

  • Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
  • Support database development and reporting capabilities related to the complaint / reliability department needs.
  • Process feedback letters and communicate to product support managers for various reporting sites.
  • Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
  • Maintain accurate documentation and files related to special projects, complaints and lot qualification.
  • Perform basic product review and failure analysis.
  • Support investigation and review of potential adverse events.
  • Assist with Post market surveillance reporting (MDRs, MDVs, MDPRs, etc.).
  • Assist in gathering information and data during FDA, ISO or other third party or internal audits.
  • Performs other duties as required.

Education and Experience

  • AS degree, preferably in a technical or scientific discipline; and/or equivalent combination of education and experience.
  • Minimum of 1-3 years’ experience with data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.

 Skills/Competencies:

  • Effective verbal and technical writing skills. Ability to communicate at multiple levels 
  • within an organization.
  • Ability to organize and manage multiple priorities.
  • Strong attention to quality and detail. Excels at generating and maintaining organized, detailed, and accurate records.
  • Strong computer proficiency (MS Office, database, etc.).
  • Able to work effectively under pressure in a high-energy environment.
  • Able to make decisions quickly and evaluate the need to obtain clarification and direction when necessary.

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