- Medical device company based in Barcelona
- QA Specialist - High visibility in the company
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A Medical Device company based in Barcelona is looking for a QA Specialist to Manage Quality Control activities, maintaining the required production and control workflow.
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.
Perfil Buscado (H/M/D)
The QA Specialist must meet the following requirements:
- University education in Sciences, Health Sciences, Engineering or similar.
- Experience in quality management according to ISO 13485 standard.
- Spoken and written English. Complete professional competence
- At least 5 years of experience in positions in the Quality area, specifically in Quality Control activities and preferably in the medical device sector.
- Additional soft skills required:Strong communication skills, attention to detail, sense of urgency, ability to adapt to a changing environment.
- Career opportunities and professional development.
- Fixed contract.