Analogic

Quality Complaint Administrator

US-MA-Peabody
2 weeks ago
ID
2017-1427
# of Openings
1
Category
Quality
Type
Regular Full-Time

Overview

Responsible for administering, maintaining, and monitoring the company's Complaint handling activities in accordance with FDA/QSR, ISO 13485 and other international regulations per the Analogic Quality Management System.

Responsibilities

  • Responsible for the integrity of Service Cases reported from the field regarding the Complaint management process 
  • Ensures all Complaints are acknowledged and completed within the required timeframe
  • Identifies Complaints that require escalation as a potential reportable event based on established criteria and applicable regulations, and then notifies regulatory affairs within specified timeframes 
  • Creates required reports and trend analyses, ensuring they are prepared and approved per internal procedures and that reports are maintained as part of the Complaint file
  • Interfaces with various departments including marketing, sales, clinical, engineering, service, regulatory, and other company staff as needed for the processing of Complaints
  • Works closely with engineering, operations, and quality assurance staff to recommend and implement appropriate Corrective and Preventive Actions 

Qualifications

Bachelor’s degree or equivalent plus a minimum of 2 years of professional experience in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR), 93/42/EEC (MDD), & ISO 13485 and other national and international QMS requirements as needed. 

 

DESIRED SKILLS:

  • Excellent written and oral communication
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations 
  • Risk management, reliability, verification, validation, and design review experience
  • Proficiency with Word, Excel, PowerPoint, Access and statistical software
  • Proficiency in Agile PLM, SAP and Microsoft CRM a plus

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