Complaints Analyst CS/VI - Wayne, NJ

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POST DATE 9/8/2016
END DATE 10/9/2016

Getinge Group Wayne, NJ

Wayne, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)
High School Diploma or GED


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.


* High School degree or equivalent. A Bachelor's degree in a Science or related technical field is preferred

* 1 - 2 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