Medical Device Compliance Specialist / Project Manager I
Los Angeles, California OR Seattle, WA (if willing to travel to LA
Initial 1-year contract (possibility to extend and/or convert depending on multiple factors)
Pay Rate Range: $24-$28/hr
Schedule Notes: Manager will consider candidates from Seattle, WA 98101) but there would be 30% travel to Los Angeles office.
Summary:
- Need technician or specialist
- Need to fulfill some FDA requirements
- Documentation skills are key! (skilled n word and excel)
- Being able to create risk analyze as well as testing documentation ideal
- Knowledge on testing activities/validation activities
- Would be responsible to produce risk management
- Everything is software related.
- Main function would be creating and reviewing risk analysis and testing based on software requirement.
- At least 2 years of related experience.
Duties:
The Project Management Specialist is responsible for planning, executing and evaluating projects according to the outlined goals and objectives and ensuring strong quality control throughout the project life cycle.
Oversee all aspects of project planning and execution including.
Working with project team, sponsor and stake holders to define project scope, goals, deliverables, resources and timing
Creating and managing detailed project plan including; objectives, tasks, work structure, timelines, resources and project risks.
Coordinate and facilitate project team meetings and proactively lead teams to accomplish project goals
Develop and implement procedures, databases, tools etc. as needed for effective project management
Identify and manage risks associated with projects and resolve any issues any problems that may arise during project life cycle.
Develop and implement procedures, databases and tools for effective project management
Track and monitor project milestones, key metrics and analyze data to report to sponsors and stakeholders
Create detailed execution plan including schedules, resources, training and ensure all are aligned prior to rollout and track and report progress.
Provide oversight of project execution through completion and ensure post implementation lessons learned are documented
Level of Education Required:
- Bachelors degree or equivalent project management experience.
Years of Experience Required:
- Minimum of 2 years previous plasma management experience or, 3 year Document management experience
- MS Office (Word, Excel, Project, PowerPoint)
- Speak, Read, & Write English.
- Effective phone and interpersonal communication skills.
Additional Info:
Hours Per Week: 40.00
Hours Per Day: 8.00
Days Per Week: 5.00
Reason: Special Project
Department: Manufacturing indirect
Job Category: Clinical/Scientific
Occupational Demands:
Occupational Demands Form # 9:
Work is performed in an office environment with exposure to electrical office equipment.
Frequently sits for 6-8 hours per day.
Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
Occasionally walks and stands.
Occasionally bends and twists neck.
Light to moderate lifting and carrying objects with a maximum lift of 25 lbs.
Frequently drives to site locations with occasional travel within the United States.
Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.