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Complaint Analyst I, Balloons Team- Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 5/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:
    5/25/2019

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Position Overview:

Provides support and assistance in the evaluation of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports. Responsible for reporting of complaints and processing of  trending analysis in accordance with Corporate, Site, and department procedures, and regulatory requirements. The Product Analyst Complaints I will interact with medical professionals to support in the complaint investigations.

Job Details:

  • Work in a team environment with members of the QA-Product Surveillance group on achieving team metrics requirements.
  • Work independently and with different parts of the organization to resolve complex issues.
  • Identifies and assesses new opportunities for improvements to work processes. 
  • Gathers and reports various complaints metrics.  Present critical information at Complaint Reviews.
  • Have good computer and data analysis skills.
  • Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.
  • Has conceptual understanding of QA functions.
  • Investigates and processes product complaints while maintaining compliance to all regulations.
  • Investigation and documentation of field clinical events and follow-up with Sales Representatives.
  • Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) and reportability requirements for various countries.
  • Assisting with Product Field Actions as required.
  • Maintenance of complaint handling site procedures.
  • Collecting follow up information related to complaints from customers.  Typically through the Sales and/or Field Service groups.
  • This is not an inclusive list of job responsibilities

Background Experience:

  • Position requires High School degree or equivalent.  A Bachelors degree in a Science or related technical field is preferred
  • Minimum 3 months prior experience performing product evaluation in a regulated industry is required.
  • Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred.
  • Prior experience with the products and their usage is highly desirable.
  • Must demonstrate effective written and verbal communication, including technical writing skills.
  • Experience with SAP is preferred.
  • Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred. 
  • Familiarity with Catsweb software is preferred.

Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.