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The Chromatography and Mass Spectrometry Division (CMD) Quality Systems Manager is responsible for development and maintenance of an effective quality management system that complies with ISO 9001, ISO 13485, FDA QSR and associated national and international requirements. This individual serves as the primary contact with ISO 9001/13485 registrars, customers, and FDA and other regulatory agencies as appropriate.
- Manage the CMD QMS to ensure it is suitable, adequate and effective to support all applicable FDA Quality System Regulations, ISO 9001, ISO 13485, and the IVD Regulation.
- Manages annual management review, procedure development, continuous improvement of the QMS, and training of personnel on the quality system processes.
- Coordinate responses to customers’ supplier questionnaires, external audits for ISO registration, as well as FDA inspections.
- Develop new process or capability as needed, e.g., CMD Risk Register, convergence on 123Compliance CAPA System; manage CMD CAPA process.
- Work with CMD Product Quality Manager and Business Unit Quality Leaders to align quality metrics and annual priorities and goals. Facilitate quarterly reviews with Business Unit and Division leaders.
- Determine priorities for projects regarding maintenance and improvement of systems; recommends priorities and actions for those controlled by outside resources (such as Corporate IT systems) affecting the CMD quality system.
- Other miscellaneous duties as assigned.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. 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, deliver medicines to market 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 services.
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