Operations · Full-time · Salt Lake City, United States
Position Summary:
Project Coordinator I provides support to the management of new and existing programs and products at BioFire Defense. Project Coordinators are responsible for the implementation and maintenance of FDA/ISO regulated Medical Devices, and associated technologies and processes. Responsibilities include contribution to project plan execution and documentation, oversite of project resources, project timelines, and deliverables.
Project Coordinators are expected to collaborate with development team(s), project managers, and operations teams to facilitate the development and implementation of design documentation and procedures according to internal Standard Operating Procedures and applicable FDA and ISO 9001/13485 regulations.
Principal Job Duties and Responsibilities:
Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System.
Facilitate project meetings, document action items and key decisions.
Draft project proposals, design documents, schedules, presentations, technical reviews.
Work collaboratively with project managers, area managers, and project stakeholders.
Use project scheduling tools to monitor and execute to project timelines.
Write, track, and manage change notices and change orders.
Independently manage small projects.
Proficient technical writing and oral skills.
Ensure consistent practices throughout all phases of the product life cycle.
May be required to obtain and maintain a DoD Personnel Security Clearance
Experience:
3+ years of project coordinator/management
Medical Device experience is preferred but not required
Familiar with Quality Management System requirements and FDA/ISO regulations
Experience with contracts and government operations is a plus
Experience working in regulated medical device manufacturing environments
Benefits:
Our EEO Policy
BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.