When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
The Complaint Investigator, Medical Device, will coordinate the customer complaint intake and handling process, providing a key interface between Customer, Technical Services and the Quality Assurance (QA), Operations, and Engineering complaint investigation teams within the Anatomical Pathology Division (APD). Track and trend medical device/instrument based customer complaints and the provision of data, charts and reports for management review.
What will you do?
- Conduct initial QA review of an instrument customer complaint and request initial follow up information/facts from Customer, Technical Services or the Distributor.
- Handle customer complaint process, including logging complaints and performing initial assessments to determine potential reportability, and assignment of investigation to the appropriate APD locations.
- Maintain data and reporting of key trends in the electronic complaint handling system.
- Train appropriate individuals in the proper use of the electronic complaint management system.
- Monitor the progress of complaint handling and investigation, and work with applicable individuals and departments to ensure timely complaint handling.
- Track/trend complaints and prepare complaint analysis reports, highlighting any adverse trends.
- Highlight any potential reportable events to QA and/or RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
- Prepare and present data/reports regarding complaint metrics for submission to Site, Divisional and Corporate Management Review.
- Plan and perform non-conformance investigations as appropriate. This may include coordinating the return of parts and instruments involved in investigations back to the factory for further investigation.
- Contribute to the continual quality and reliability improvement of APD products and services.
- Maintain working relationships with division wide instrument based strategic partners and third party organizations.
- Ensure policies, procedures and practices are in compliance with global quality and regulatory requirements and meet the needs of our customers and Quality Policy.
- Perform tasks to support the Quality System and Quality Policy as directed by QA management.
- All other duties as assigned.
How will you get here?
- A minimum of an Associate's degree with preference for a Bachelor's degree. Mechanical Engineering discipline is a plus.
- Experience working with FDA regulated products in medical device/IVDpreferred with biotechnology/pharmaceutical or dietary supplement considered.
- Knowledge of ISO 13485, FDA QSR Part 820 / 803 requirements preferred.
- Experience working with complaint handling and/or CAPA and management review.
- Knowledge of statistical data analysis tools and techniques.
- Excellent interpersonal skills.
- Ability to work in a timeline driven environment.
- Excellent written and oral communication skills.
- Excellent computer skills, particularly spreadsheets/graphical software tools such as Excel.
- Ability to travel less than 5% (US, European & International)
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.