MDR Quality Engineer

Full Time
North Haven, CT
Posted
Job description
Role: MDR Quality Engineer
Location: North Haven, Connecticut
Keywords to search: Quality Engineer, IQ, PQ, OQ documentation, Process Validation , Medical devices, MDD, MDI, Labeling

• 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

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