- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Leads and monitors projects throughout development, initiation, planning, execution, control and closing.
- Acts as the point of contact and expert for assigned projects.
- Develop risk assessment, specifications, validation plans, protocols and reports that support the qualification and validation of manufacturing processes.
- Develop and maintain accurate timelines for multiple projects.
- Plan and oversee the implementation of new and/or improved manufacturing processes and equipment
- Schedule meetings, create agendas, documents meeting minutes, correspondence, and presentations
- Communicates, prepares and presents reports, summaries and analysis to support the project and status of projects.
- Creates and maintains relevant project documentation throughout the project.
- Applies project management best practices throughout the project lifecycle
- Investigates, creates, and develops new methods and technologies for project advancement.
- Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Promote QSR and regulatory compliance into assigned projects.
Studies and Experience:
- Minimum of Bachelor’s degree in related scientific or engineering field.
- Minimum two years in project management is desired.
Skills and Qualifications:
- Knowledge of validation strategies as they pertain to the medical device manufacturing industry
- Ability to relate with people at all levels within an organization
- Must work well independently as well as in a team environment
- Must be an effective communicator
- Must be able to work on multiple projects simultaneously