Quality Management (QM)

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Job Description:

Outcomes: The successful candidate will lead the strategic and tactical initiatives of the

supply chain with a focus on production planning, quality management and assurance, product data management, and compliant

manufacturing processes and information technology solutions in a medical device environment.

-Responsible for all

aspects of the development and implementation of assigned projects.
-Manages projects from project Initiation through

Close.
-Defines project scope and objectives, develops detailed work packages, schedules, project
estimates,

resource plans, and status reports.
-Will lead and direct the work of others.
-Communicates project status to

all stakeholders of a project.
-Provides mentoring, technical, and analytical guidance to team.
-Requires a

bachelor's degree or equivalent in a related area and generally 10+ years of
experience.
-Possesses the

ability to work and make decisions independently.
-Uses people, process, and information technology to ensure that the

customer's business needs
are satisfied.
-Collaborates with all levels of business resources including

outside consultants to develop an
understanding of work flows, information needs, reporting requirements and assist

with
implementing existing or new technology to support those requirements.
-Responsible for assisting with

routine and non-standard maintenance, upgrades, programming
changes and analysis of system performance.
-Must

have a recognized expertise in understanding how information technology impacts
business processes.
-Has

accountability for ensuring that the internal Customer's needs are met by the application
of information technology

solutions.
-Understands FDA requirements in a medical device manufacturing and quality system

environment.

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Email resume in Word format to : kwolsko@caliberoneconsulting.com