Project Manager - Quality Management Systems

Role name:

Project Manager

Role Description:

Project Managements Quality Management Systems PMP FDA Power Point Presentation Strong communication skills ISO 13485 Medical Device Regulatory Standards Quality Compliance CAPA / NC

Competencies:

EIS : Medical Device & Regulations

Experience (Years):

68

Essential Skills:

Project Manager A minimum of Technical/Engineering Degree with 10 years of related experience Medical Device Product Management domain. Project Management Professional (PMP) certification is required Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques. Knowledge on Quality Management and its tools & techniques Knowledge about FDA ISO 13485 and compliance regulations Knowledge on Medical Device Regulatory Standards MDD and MDR Knowledge on NC CAPA Audit processes Knowledge in Statistic Risk Management and Design control Have firsthand knowledge/experience in creating process flow map developing project plan using MS Project Gantts Organize and Manage individual project plan/schedule Excellent Interpersonal / communication skills Organizational / planning and Project management skills Understanding of Marketing & market research strategies Personal computer skills Windows: word processing project planningpresentation email web browsers & spreadsheet software Experience in Quality Management Systems (QMS) 7 in Years in Medical Device Industry

Desirable Skills:

Under (e.g. limited supervision general direction etc.) and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position: Meet with project core team to review requirements and deliverables of each project. Support closure of CAPA/NC Support Change Management activities if any Support Quality Documentation Support in external and internal audit Interpret new/ upcoming quality/ regulatory requirements and provide guidance Provide technical support on organizations quality processes within QMS Creation and Execution of Quality Plans Delegate project tasks based on area responsibility. Track project performance specifically to analyze the successful completion of short and longterm goals. Develop comprehensive project plans to be shared with project team as well as Management Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures May supervise/lead and provide technical guidance to lower level personnel. Performs other duties assigned as needed Take part in making decisions on selection of suitable team based on the project needs in concurrence with the customer Meet delivery promise in terms of budget and timescales Monitor project progress and team performance and make necessary changes to the team as needed to ensure achievement of project goals Work within a multidiscipline team Liaison with customer designated point of contact and functional area point of contact Responsibility for team and crossfunctional communications; lead phase and business reviews project meeting minutes issues log metrics and other key communications Progression to management of larger and more complexA minimum of Technical/Engineering Degree is required

Country:

United States

Branch City Location:

TCS Los Angeles
IRVINE
Irvine CA