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These professionals follow the ISO quality regulations focused on the processes, Good Practice regulations (GLP/GMP/GCP) and the CE marking for the certification of medical devices in order to ensure that the actions carried out comply with requirements previously set forth by law and by the company's objectives, and that these actions can be reproduced, traceable, properly documented and that the staff is perfectly qualified to carry out the assigned tasks.

These professionals work in two areas: quality control and quality guarantee. They ensure the compliance of internal specifications with the standards and good manufacturing practices. The quality guarantee (define the framework and reference standards) and quality control (define the processes, internal verification systems and application of corrective actions). They must define the quality assurance strategy, the types of regulations which must be fulfilled, the allocated resources and the necessary checks on technical teams and staff.


Quality guarantee:
  • Supervise the drafting and updating of the SOP (Standard Operating Procedures) necessary to describe, organise and manage the processes under their responsibility.
  • Write up validation protocols and coordinate the execution.
  • Coordinate and carry out internal audits.
  • Manage possible deviations and the resulting corrective actions.
  • Manage the control of the changes carried out.
  • Prepare all the documentation necessary to obtain quality certifications.
Quality control:
  • Carry out the analyses to control the quality of the raw materials and finished products.
  • Assemble the devices, prepare the tests, conduct the tests, and analyse and communicate the results to the head office.
  • Oversee the maintenance and functionality of the laboratory tools to ensure safety in the quality control process.
  • Ensure regular control of the material and guarantee optimal working conditions.

Quick access and copyright:

Centre per al desenvolupament professional Porta22

Barcelona Treball (Porta22)
Llacuna, 156-162, 08018 Barcelona

Monday to Friday from 9 to 18 h

Generalitat de Catalunya
Unió Europea FEDER
Unió Europea FSE