Program management involves a comprehensive overview of all your projects.
- manage product development projects, including budget, timeline, and suppliers
- coordinate product development / design control documentation and deliverables, ensuring FDA and ISO compliance
- assist with design history files (DHF), 510(k) submissions, technical files, and other regulatory submissions
- ensure product risk management practices and documentation are compliant and streamlined
- manage internal projects and teams, including quality system initiatives, corrective & preventive action (CAPA) implementation
- conduct internal auditing
Business Development must be pointed in the right direction and align with the overall strategy for the company.
- evaluate current product positioning and market opportunities
- connect with additional business prospects
The adequacy of the skill sets within an organization need to be carefully evaluated to ensure they meet current and future needs. In order to achieve maximum operational effectiveness, Creo will:
- identify and evaluate key business processes
- streamline business operations to maximize overall operational flow
- audit and assess effectiveness of quality system procedures, thus ensuring FDA and ISO compliance
- identify manufacturing and business processes that are in need of improvement
- assess workforce resources and determine if additional training or screening of new employees is necessary to meet the needs of the organization