Tarrytown, United States
4 months ago
This role will have responsibility to assist in the management, coordination and scheduling of Quality-related IVDR projects within the Laboratory Diagnostics Program Management Office for the IVDR LD QT Element Team. This project is focused on driving QT elements of the IVDR Program for Laboratory Diagnostics and will interface with the LD IVDR Functional Team Leads, IVD Workstream Leads and internal key customers. Strong organizational, communication and scheduling skills a must.
- Facilitate project prioritization activities.
- Define scope and magnitude of each project.
- Establish business cases, aligning project targets with business goals.
- Schedule, moderate and manage/document team meetings.
- Assist in the development of project plan schedule(s)
- Drive project plans and track actions, objectives, etc.
- Ensure cross-functional collaboration and cooperation.
- Implement necessary contingency and mitigation plans.
- Communicate effectively to key stakeholders.
- Escalate issues in a timely manner to assure expedited resolution.
- Assure compliance to standards, laws and regulations.
- Ensure appropriate project documentation, including development of Quality Plans, schedules, where needed.
Required Knowledge/Skills, Education, and Experience
- Bachelors Degree in a technical field
- Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization
- 5+ years of experience managing complex projects
- Strong leadership, listening, verbal and written communication skills
- Attention to detail
- Must be able to work independently, be self-motivating and act as a change agent
Preferred Knowledge/Skills, Education, and Experience
- Project Management and or Program Management
- PMP certification
- Structured problem solving
- Previous experience or knowledge of accredited quality management standards such as ISO 13485
- IVDD experience