Validation system:
Maintains Validation system. Analysis and continuous
improvement.
Organization the validation and similar activities, building of
temporary multifunctional teams.
Participating in new/alternative materials and combinations
testing/validation within multifunctional teams;
Maintains Validation master plan, planning of validation,
qualification and similar activities, maintain documentation and
data base;
Maintains QMS documentation related to validations, qualification
and similar activities;
Performs training in the matter. Maintaining of training
documentation;
Control and measurement devices (CMD) system:
Maintains CMD system: QMS documentation related, records, data
base. Maintains CMD master calibration plan;
CMD system continuous improvement and efficiency increase;
Work on continuous cost reduction;
Knows the related to a CMD standards;
Knows the related to Medical device standards` requirements
concerning CMD and assures their implementing and development;
Maintains the planning and assurance of the CMD system,
calibration, distribution;
Monitoring of CMD through the organization – use, condition, need
of additional activities;
Organising of all necessary activities for achievement of all
planned and required activities;
Performs training to the staff in CMD field as assurance of proper
use and relative results. Maintains the training documentation;
Performs tasks required by Director Quality and RA and/or her
direct manager upon daily and occasional necessities;