Thermo Fisher Scientific QA/QC Engineer I - 1st Shift in Frederick, Maryland
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.
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.
*Minimum Qualifications (must have)
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.
*Preferred Qualifications (nice to have)
2 year experience in IVD, Medical Device or Pharmacuetical industry
Working knowledge of cGMP and it's appropriate application.
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.