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Job ID :
42699BR
Location :
US - Kansas - Lenexa
:
Job Description
  • Develop, maintain and monitor programs for compliance with the Quality Systems Regulations and internal procedures.
  • Assist the Quality Systems Manager in the preparation and control of regulatory documents
  • Prepare and control documents in support of product recalls and field actions.
  • Input all information as necessary for new products including but not limited to formulation, processing and labeling data for product manufacturing.
  • Perform maintenance as necessary to existing product information.
  • Participate as team member in Vendor, Customer, and Parent Company Audits.
  • Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO 9000 series, and internal procedures.
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Listen to and follow verbal and written instruction given in the English language.
  • Report any actual or potential safety hazards to the Supervisor, Human Resources, Safety Specialist or Senior Management.

    In addition, other duties may be assigned as the need arises.

    Minimum Requirements/Qualifications:

  • B.S. degree, preferably in a science or computer field.
  • Experience with Microsoft Office Suite programs.
  • Preferred three years of experience in quality, product reliability, and/or product development in a quality, manufacturing environment.
  • Preferred knowledge of FDA, Medical Devices, and ISO regulations for device manufacturing.
  • Possess prudent and practical decision-making abilities.



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.
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