Quality Engineer - Missoula, United States - Longwood University

Longwood University Missoula, United States

Found in: Lensa US 4 C2 - 5 days ago

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Title:
Quality Engineer/Validation engineer

Here is a short summary for the MDR

Quality Engineer:

The Quality Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution. Assist with the review and coordination of the Process Validations and provide guidance and resolution of remediation activities.
Working knowledge of manual and automated/semi-automated equipment. The thrust of this assignment is related to pre-printed materials and labeling.
Collaborate on the project team and work under the direction of the Project Manager in a fast-paced environment supporting program initiatives and compliant with company best practices.
Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.
2 years minimum experience

Nice to have:

Working knowledge of medical device manufacturing a plus
Working knowledge of product packaging and sealing equipment a plus
Working knowledge of EU MDD (Medical Device Directive) and MDR (Medical Devices Regulation) requirements a plus
Working knowledge of Unique Device Identifier (UDI) regulations a plus

Thanks,

Anamika Singh||Life Sciences Recruitment Manager||
#J-18808-Ljbffr

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