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Quality Engineer I, Complaints CS/VI - Wayne, NJ - Wayne, NJ - Getinge

Date de Publication 6/1/2019

Résumé de l'offre

  • Type d'employé :
    Employé à plein temps
  • Expérience :
    Not Specified
  • Date de Publication

Description de l'offre

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 Function Summary:

The Quality Engineer Failure Analysis I provides technical support to the complaints and other quality department functions.

Primary Responsibilities

  • Conduct the evaluation and decontamination of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports. 
  • Work in a team environment with members of the QA-Complaints group on achieving team metrics requirements and assist in writing reports on various complaints metrics. 
  • Support in the timely, accurate failure investigations on returned product to support root cause analysis.
  • Coordinate activities regarding Failure Analyses, working closely with Manufacturing Engineering
  • Assist in trending, Product Inquiries, and other activities as required.
  • Identify, initiate, and/or performing CA or PA activities, as well as other areas within the Quality System including, but not limited to, Internal Audits, Supplier Quality, Nonconforming materials, and HHEs
  • Coordinates procurement/shipment of samples to testing laboratories, evaluation and reporting results.
  • Actively identifies, pursues, and provide recommendations for assuring patient safety and compliance to regulations.
  • Assist the complaint team during regulatory agency, notified body or other 3rd party audits.
  • Engage with different parts of the organization to resolve issues. Review and provide recommendations for new opportunities for improvements to work processes. 
  • Completing both short and long-term projects/assignments as needed. 
  • Ensure timely closure of complaints to comply with FDA requirements.

Required Skills and Abilities:

  • Must have familiarity with laboratory work in the medical devices industry, the ability to analyze and solve problems, and the ability to communicate effectively across departments. 
  • Must demonstrate affective time management, project management skills and be able to practice good safety standards and returned products safe handling techniques.
  • Proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred. Intermediate computer skills are ideal.

Experience and Education Requirements:

  • Bachelor’s degree in Engineering, Science or related field is required.
  • One to three years of experience in complaints quality engineering, or related functions or M.S. and no experience. 
  • Experience in a FDA regulated industry or ISO certified organization 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

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.