Company overview
About Us At
St. Jude Medical every one of us plays a role in our collective ability
to save and improve lives. As an organization, we want to continue to
grow and lead our industry in changing the way the world views the
treatment of expensive, epidemic diseases. By seeing things from a
different perspective, using our imagination, leading with character,
and working with passion, we all have a role to play in making what we
do possible. Are you ready to join us? We are an Equal
Opportunity/Affirmative Action Employer.
Description
We
are seeking an high caliber Documentation System Specialist. This
position is responsible for effective Project Lifecycle Management
System (PLM) user activation, system support and training. This position
will also provide technical support to Documentation Services as
required and renforce adherence to written documentation policies and
procedures.
Employees act on their strong desire to make a
difference, partner with others and put ideas into action. Employees are
engaged by a work culture that is team oriented, fast paced and
progressive.
Impact this role will have on St. Jude Medical:
1) PLM System Support
· PLM User Activation for CATD Division
· Maintain process, procedure and control the archival of PLM training records across all sites that perform training.
· Provide PLM user support, including
but not limited to, implementation of system improvements, data
migrations and day to day customer support.
· Subject Matter Expert in PLM.
· Identify and resolve issues related to PLM.
2) PLM System Training Maintenance
· Create and maintain PLM training material as needed
· PLM website maintenance
3) PLM System Maintenance
· PLM system update support, such as,
understanding and defining changes requested, testing and data migration
activities.
· Update applicable documentation such
as Standard Operating Procedures or Work Instructions to align with
system updates
4) Documentation Services Support
· Provide monthly/quarterly metrics to Documentation Services group
· Create Change Requests for personnel as requested.
· Provide training as required to Documentation Services
· Special projects as required
· Evaluate activities and identify areas of improvement and carry out improvement activities.
Other Duties:
· Support all Divisional initiatives as
identified by divisional management and in support of Quality Management
Systems (QMS), Environmental Management Systems (EMS), and other
regulatory requirements
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
Qualifications:
· High School diploma or equivalent required.
· 3+ years’ experience in an FDA or ISO controlled industry.
· Expertise in PLM
· Knowledge of FDA, GMP, and ISO 13485
· Solid communication and interpersonal skills
· Solid computer skills and report writing skills
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