Quality Assurance Specialist

Project Quality Assurance Specialist needed to work with a product development team in dynamic Medical Device Research and Development environment.

Integrate with Design and Development teams to be able to provide assistance and guidance on Quality System processes
Work with the Design and Development teams to generate compliant documentation
Maintain Design History File (DHF), including tracking deliverables, for one or more products throughout development
Work with the Project QA Manager to ensure development processes are compliant with procedures
Review and approve quality history records under direct supervision
Assist in investigation and resolution of project specific Corrective and Preventive Actions under the direction of the Project QA Manager
Assist Project QA Manager in facilitating project quality meetings
Conduct process audits against written procedure and identify process improvements under direct supervision
Participate in the development and/or revision of applicable standard operating procedures
Understand and provide guidance to development team on compliance with the FDA QSR and ISO 13485 Standards
Conduct internal audits of the company quality system and project-specific plans and procedures
Assist in FDA, customer and regulatory inspections

Qualifications:

High school diploma with 5+ year's relevant quality experience. Bachelor's degree in a science or related discipline preferred.
QSR Part 820 and ISO 13485 experience a plus
Experience working with cross-functional teams