Quality Engineer Jobs

Job Title : Quality Engineer

Location : North Haven, Connecticut

• The Quality Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution.
• Conduct, coordinate and aid in formal Process Validations including protocol development and execution.
• Generate and revise Bills Of Materials as applied to Versioning.
• Working under the guidance of the Senior and/or Principal Engineer.
• Excellent organization, Planning, Computer skills, Technical writing, Communication skills.MS Office Suite and Outlook.
• Working knowledge of medical device manufacturing a plus
• Bachelor's degree in Engineering is required
• Working knowledge of EU MDD (Medical Device Directive) and MDR (Medical Devices Regulation) requirements a plus
• Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
• 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.
• Working knowledge of manual and automated/semi-automated equipment.