Job ID :
US - Kansas - Lenexa
- Responsible for the implementation of daily complaint/product handling, investigation, monitoring, follow-up, and closure of all designated complaints/product issues. This includes data entry and report generation for various aspects of quality notification handling.
- Oversee all Quality Notification unit functions including applicable Quality Notification Reviews & Closure, Reporting & Trending, QRB, FIA, and Customer & FDA Advisories.
- Test products with ATCC cultures and/or patient isolates.
- Prepare written letters for customers.
- Review device history records, processing records, and device master records for anomalies.
- Communicate with customers and other departments to gain necessary information to investigate notifications.
- Serve as expert within Thermo Fisher Scientific for Complaint/Product issues.
- Serve as backup for technical literature (IFU, Labeling, etc.) reviews / approvals.
- Participate in development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.
- Report any actual or potential safety hazards to the Quality Notification Supervisor, Human Resources, EH&S Department, or Senior Management.
- Other special needs as required. Thermo Fisher Scientific is committed to providing a barrier free work environment for all employees. Employees are encouraged to submit in writing, to the Human Resources Department, any modifications or special accommodations deemed necessary to perform the essential functions of their job.
In addition, other duties may be assigned as the need arises.
- Possess a Bachelors degree in microbiology, science, medical technology, or related field.
- Possess a minimum of one (1) year of experience in a quality, manufacturing environment, or clinical experience.
- Prefer experience with microbiology.
- Prefer experience working with prepared media.
- Possess prudent and practical decision-making abilities, good written and verbal communication skills (in English), and ability to work independently without direct supervision, good organizational skills, and effective interpersonal skills.
- Possess the ability to manage many tasks and in an organized fashion.
- Possess the ability to write technical letters for customers.
- Possess the ability to read and understand technical documents.
- Possess intermediate computer skills, computer software and PC experience, including Excel, Word, Outlook, Adobe, and SAP.
- Prefer experience in laboratory methods and familiarity with FDA and/or ISO regulations for device manufacturing.