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Specific
Responsibilities
·
Reviews the Smart Complaint database
for complaints ready for
investigation under role and actor
notifications
·
Ensures the Complaint Coordinator
identifies all potential reportable
events or adverse events,
investigates personally and with
other Complaint Analysts
·
Presents potential reportable events
or adverse events to the Global
Regulatory Affairs team and
appropriate Quality Engineer. Advise
Regulatory and QE to communicate
directly to identify root cause and
a resolution path through
Manufacturing Engineering or R&D
·
Ensures appropriate failure mode
classifications are assigned to
allow precise trending for data
analysis purposes
·
Elevates complaints for
investigation subject to agreement
with the Lead Complaint
Analyst to ensure these are in line
with CAPA priorities
·
In
line with CAPA priorities,
identifies when appropriate Quality
Engineer is needed to perform a
device evaluation and / or failure
investigation and presents lead
complaint to the QE
·
Designs, implements and monitors
suitable close out templates.
Obtains approval from Lead Complaint
Analyst before use
·
Supplies the Complaint Coordinator
and Analysts with approved close out
templates for repeats of issues
currently under investigation by
Quality Engineering or for repeat
occurrences of issues which have
root cause already identified
·
Progresses nominated Quality
Engineers for timely identification
of root cause to complaints under
investigation
·
Closes out the lead complaint once
failure investigation is complete as
advised by the nominated QE
regardless of whether resolution has
been implemented post root cause
analysis
·
Provides information from the
Complaint database to the
Departmental Data Analyst and other
KCI business functions as required
·
Provides training to but not limited
to PIRT and other KCI Call Center
teams
·
Participates in any and all
reasonable work activities as may be
deemed suitable as assigned by
management
·
Works in accordance with company
policies and procedures |
