Post Market Surveillance Analyst

Location

Port Washington, NY

Description

In compliance with current good manufacturing practices, the Post Market Surveillance Analyst is responsible for supporting the complaint handling Quality system through the timely assessment, processing, distribution of information, and communication of alleged product quality deflects for all medial devices within the scope of Drive DeVilbiss Healthcare.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities will include:

  • Triage all received complaints in order to immediately identify any potentially expedited quality/compliance issues
  • Responsible for recording quality complaint information received including:
  • Entering new complaints
  • Determine when a complaint should be investigated or recorded for trending purposes only
  • When a complaint sample should be retrieved for evaluation
  • Complete daily workload while maintaining consistent, quality work and compliance with established procedure and timelines
  • Contact reporter, as necessary, to gather additional complaint information to ensure we are adequately evaluating the alleged complaint

Requirements

QUALIFICATIONS, KNOWLEDGE, AND SKILLS :

  • Understanding of Code of Federal Regulation (CFR) for medical devices with emphasis on complaint handling requirements. 21 CFR 820.198 preferred
  • Experience with computer systems including database, spreadsheet, and word processing applications
  • Excellent oral and written communication skills
  • Organizational skills
  • Must be flexible with regard to changing and conflicting priorities, able to easily shift gears in response to ambiguity and the needs of the situation
  • Must have the ability to address obstacles with energy and determination and exhibit commitment to change

Education and Experience:

  • High School diploma or equivalent, required
  • 1 - 3 years experience, peferred

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