The Anatomical Pathology Division (APD) provides laboratories with the broadest portfolio of instrument and consumable solutions, from specimen collection and grossing to advanced staining and cover slipping. The Division generates $400MM in annual revenue and has 1,500 employees in 13 countries. The anatomical pathology product line includes Richard Allan Scientific, Erie Scientific, Microm, Shandon, and Lab Vision.
The Complaint Coordinator coordinates the customer complaint intake and handling process, providing a key interface between Customer/Technical Services and the QA/Operations/Engineering complaint investigation teams. This position takes responsibility for the tracking & trending of customer complaints and the provision of data, charts and reports for management review.
+ Responsible for the initial QA review of a customer complaint and requesting initial follow up information/facts from Customer/Technical Services or the Distributor as required.
+ Responsible for the customer complaint handling process, including logging complaints and performing initial assessments to determine potential reportability, and assignment of investigation to the appropriate APD locations.
+ Responsible for the maintenance of data in the electronic complaint handling system.
+ Responsible for training appropriate individuals in the proper use of the electronic complaint management system.
+ Responsible for monitoring the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met.
+ Responsible for tracking and trending complaints and preparing complaint analysis reports, highlighting any adverse trends.
+ Responsible for highlighting any potential reportable events to QA and/or RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
+ Responsible for preparing & presenting data/reports regarding complaint metrics for submission to Site, Divisional and Corporate Management Review.
+ Responsible for planning & performing nonconformance investigations when required. This may include the coordination of return parts and instruments involved in investigations back to the factory for further investigation.
+ Responsible for contributing to the continual quality & reliability improvement of APD products and services.
+ Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
+ Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
+ High School Diploma or equivalent required, Associate or Bachelors Degree preferred
+ Experience working with FDA regulated products (Medical Device/IVD preferred)(pharmaceutical or dietary supplement experience is acceptable)
+ Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements preferred
+ Experience working with complaint handling and/or CAPA & management review
+ Knowledge of statistical data analysis tools and techniques
+ Excellent interpersonal skills
+ Ability to work in a timeline driven environment
+ Excellent communication skills both written & oral
+ Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)
+ Less than 5% travel (US, European & International)
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific