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 ||
