MDR Quality Engineer-Connecticut - Georgia Tek Systems

MDR Quality Engineer
North Haven, Connecticut
Contract

U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor currently
Required Skillset

• Minimum of 2 year of experience

• 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.

Nice to have skills:

• 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