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