Description
Purpose of the Position:Under the direction of the Vice President, Quality Assurance and Regulatory Affairs , the Quality Assurance Specialist or Manager will continue development and implementation of DxTerity's Quality System to support product development, design transfer, outsourced manufacturing, clinical studies and regulatory submissions in compliance with the Quality System Regulation (21 CFR 820) and ISO 13485:2003. The position will be responsible for assuring company-wide training in and compliance with all Quality System policies and procedures. Near-term supervisory responsibilities will be minimal; at most, one additional junior QA position may be added in the next year to perform routine tasks such as document control.
Role and Responsibilities:
- Develops written policies and procedures required for establishment of a QSR-compliant Quality System.
- Works with Management and Staff to develop practical solutions to achieve regulatory compliance.
- Trains Management and Staff on policies and procedures.
- Performs internal audits to assess compliance, and works with Management and Staff to develop practical solutions to achieve compliance.
- Assists in development of Quality Plans.
- Maintains all records and documents within the Quality System.
- Assures all products, processes and systems comply with DxTerity policies, procedures and specifications.
- Performs supplier qualification, supplier audits and monitors supplier quality.
- As a member of project teams, assures compliance with Design Control and Risk Management policies and procedures.
- Participates in the planning and execution of required validations
- Oversees CAPA program effectiveness
- Participates as assigned as a Quality representative on project teams
- Assists in the development and monitoring of quality metrics.
To find out more about Real please visit www.realstaffing.com