Supervisor, QA Product Complaints - 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.



Position Overview:

Leads the complaint handling team to assure proper handling of all complaints and compliance with all applicable government standards, including but not limited to FDA Medical Device Report (MDR).  Responsible for reporting of complaints, evaluation of returned products and processing of complaint trends.  Works closely with internal departments and may interact with hospital staff, members of servicing and sales force, and/or other external personnel.


Job Details:

  • Leads efforts for compliance with all Food and Drug Administration (FDA), European Union Medical Device Directive (MDD) and all other applicable governing body regulations governing adverse event reports such as Medical Device Reports (MDR), Medical Device Vigilance (MDV), and Alternate Summary Report (ASR).
  • Supervise, lead and coordinate efforts of the complaint handling team to assure proper tracking and complaints are processed to applicable requirements.
  • Assure timely and accurate failure investigations of product complaints leading to root cause of the failure.
  • Prepare information for complaint meetings and lead the review and discussion of the information.  Provide additional analysis as required.
  • Assures timely closure of complaints.
  • Participate in FDA and other 3rd party audits.
  • Lead efforts for maintenance of and upgrades to complaint handling SOP’s and software tools.
  • Follow up with customers and/ or sales representatives as needed.

Background Experience:

  • Minimum 2yrs. experience in the medical device industry is required. Minimum 5yrs. complaint handling experience.
  • Must have at least 6 months in a lead level role.
  • Familiarity with an automated complaints system required; TrackWise software is preferred.
  • Bachelor’s Degree in Life Sciences or Engineering and 4-5 years of related experience and/ or training; equivalent combination of education and experience. 
  • Ability to communicate clearly and concisely (written and oral), including technical writing skills.
  • Must have knowledge of and experience working with quality systems and 21 CFR 820, ISO 13485, MEDDEV 2 12-1 (93/42/EEC), and other related standards.
  • Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples and procedures related to Complaint-Handling and MDR / ASR / vigilance reporting in accordance with all applicable regulations is preferred.
  • Experience with SAP is preferred.
  • Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications 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



#CBC#

#LI-CA1

INDCA



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.