Thermo Fisher Scientific Instrument Complaint Coordinator in Kalamazoo, Michigan

Job Description

Company Information

About Us

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and approximately 57,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Position Summary:

This position 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.

Key Responsibilities:

  • 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.

Minimum Requirements/Qualifications:

  • High School Diploma or equivalent required, Associate or Bachelor’s 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)

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.