QA Specialist

The QA Specialist will have the folowwing responsabilities:

• Manage Quality Control activities, maintaining the required production and control workflow, developing the necessary SOPs and associated documentation within the organization's Quality Management System.
• Plan, execute and record inspection and testing of incoming, in-process and outgoing products/lots in accordance with the approved procedures/protocols to confirm conformance to specifications and quality requirements.
• Establish batch release protocols. Plan, execute and record batch release testing ensuring product specifications are met for lots to be released to the market.
• Compile and review manufacturing and quality control documentation (DHR) for manufactured lots.
• Review devices labelling to ensure applicable regulatory requirements are met.
• Participate in the assessment, control and implementation of manufacturing and quality control process changes.
• Elaborate/review equipment and facilities (including cleanroom) qualification and re-qualification plans/protocols. Coordinate, execute/review and oversee equipment and facilities (including cleanroom) qualification and re-qualification activities.
• Elaborate/review processes and test method validation and re-validation plans/protocols. Coordinate, execute/review and oversee process and test method validation and re-validation activities.
• Assist in the coordination, planning and execution of the equipment calibration and maintenance activities.
• Assist in the documentation of deviations, non-conformities and CAPAs related to facilities, equipment and manufacturing and control processes.
• Guarantee that regulatory and quality requirements are met regarding applicable regulatory and standards requirements for the placing and/or maintaining products on the market.
• Assist in the preparation of the technical documentation required by the Health Authorities for the manufacturing activity license in relation to facilities, equipment and/or processes or other related documentation.

• Actively collaborate in internal and external audits and inspections of Health Authorities and Notified Bodies (focused on the production, control and storage processes).
• Provide ongoing training to all staff on Quality issues, as well as ensure its application and compliance.