INBRAIN Neuroelectronics is seeking for a Quality Engineer to support the quality team with the implementation of the Quality Management System and work closely with the Microfabrication team to ensure quality is understood and implemented throughout the entire company.
- Provide support to the Microfabrication organization, maintaining compliance to ISO 13485 requirements in our cleanroom facilities in Bellaterra (Barcelona).
- Execute and maintain several QMS processes and support the process owners;
- Create and maintain QMS documentation, such as standard operating procedures;
- Work with relevant departments and stakeholders to investigate non-conformances, defects and process failures in general;
- Support analysis and improvement process and implement corrective actions to prevent re-occurrence of compliance issues;
- Ensure that QMS procedures are followed and provide advice and guidance on quality related aspects.
- Support the manufacturing team to ensure compliance of batch documentation to internal requirements (including internal releases);
- Ensure acceptance and Inspection activities for each product are established, appropriate, and carried out in accordance with procedures and Control Plans;
- Establish inspection standards, plans, frequencies, and test methods for the product realization process;
- Ensure that a consistent approach to acceptance and release is developed and maintained.
- Support risk management activities;
- Lead and coordinate the creation and maintenance of FMEAs;
- Support the development team in the creation of DHF documents, and maintenance of traceability throughout the design process.
- Support Internal Audit process and Supplier Audit process as per ISO 13485 requirements