Insulet Corporation

Post Market Surveillance Specialist

US-MA-Billerica | US-MA-Billerica
2 months ago
Category
Quality Assurance / Quality Engineering

Position Summary

The Post Market Surveillance Specialist position is accountable for individual work projects as well as training and documentation in support of other team members. The Specialist may also review and monitor data and document quality, as requested by the manager. This position will provide administrative support to the department through assistance in preparation of 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 also requires some regulatory assessment capability along with MDR/Vigilance reporting. The position involves system level comprehension, attention to detail, organization, and constant interaction within the business to the accomplishment of the company goals.

Responsibilities

  • Track all stages of the Complaint Documentation process including:
    • Data Analysis,
    • Reporting and Trending,
    • Documentation Review,
    • Coordination of complaint and lot qualification data,
    • Device history reviews,
    • Review and closure of certain categories of complaints.
  • Maintain accurate documentation and files related to special projects, complaints and lot Qualification.
  • 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.
  • Assist during FDA, ISO or other third party or internal audits.
  • Train others on the requirements of the Complaint Coordinating activities, including follow-up with the Customer Care Group.
  • Support review and investigation of adverse events
  • Post market surveillance reporting (MDRs, MDVs, MDPRs, etc.).
  • Perform basic product review and failure analysis.
  • Performs other duties as required.

 

Education and Experience

  • AS degree highly desirable, preferably in a technical or scientific discipline; and/or equivalent combination of education and experience.
  • Willingness to pursue additional learning and build qualifications in professional field, as required.
  • Minimum of 3-5 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:

  • Ability to demonstrate system level expertise of databases with the ability to train on these identified systems.
    Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
  • Ability to organize and judge priorities.
  • Excels at generating and maintaining organized and accurate records; PC skill, word processing, spreadsheet, database.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

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