Complaints Analyst II - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 8/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:
    8/30/2018

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.



Job Title:  Complaints Analyst


Position Overview:

This position will provide support and assistance in the evaluation of Product Complaints for Medical Device Report and Vigilance reports. Responsible for reporting of complaints, evaluation of returned products and processing of trending analysis, in accordance with Corporate, Site, and department procedures, and regulatory requirements. This position will interact with medical professionals to support in the complaint investigations.


Position Details:

  • Work in a team environment with members of the QA-Product Surveillance group on achieving team metrics requirements.
  • Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
  • May serve as a subject matter and technical expert within functional area.
  • Works 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.  Presents 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.
  • Responsible for communicating business related issues or opportunities to next management level.
  • 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.

Qualifications:

  • Associates degree or equivalent work experience.  A Bachelor's degree in a Science or related technical field is preferred
  • Minimum 3 years related work experience in Quality Complaints.
  • Prior experience performing product evaluation in a regulated industry is preferred.
  • 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.



All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Getinge is an EO employer – M/F/Veteran/Disability


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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.