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 Quality Assurance Engineer works as part of the QA team at our Frederick, Maryland facility. This person’s core responsibility will be reviewing Device History Records and associated documents prior to release and shipment to ensure all requirements and specifications are met. In addition will provide QA/QS support and guidance to functional groups.

What will you do?
 

• Review Device History Records (DHR’s) and associated documents to ensure that all documents and specifications are met. Identify non-conformances and trend/report device history batch issues.
• Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations. Resolve incomplete or unexplained issues found during the batch review with manufacturing.
• Review finished good batch records and perform finished good inspections as required
• Verify finished good labels for accuracy
• Compile various reports, related duties, and special projects as assigned.

• Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering) or equivalent.
• Working experience in a regulated industry.
• Effective communication skills are required, both written and verbal.
• 2 year experience in IVD, Medical Device or Pharmaceutical industry
• Working knowledge of cGMP and the appropriate application.