(Microfabrication) Quality Engineer

Barcelona          ·           Full time Temporary

Your Mission

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.  

Key Responsibilities:

• 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  

Your Profile

• Master’s degree or equivalent in Engineering, Life Sciences or another relevant discipline.  
• 1-3 years’ experience in quality in the medical device industry (preferred) 
• Good knowledge of ISO 13485, ISO 14971, MDR 2017/745, FDA 21 CFR 820 (preferred). 
• Familiar with requirements for process validation (IQ, OQ, PQ) (preferred) 
• Team player and positiveindividual. 
• Attention to details and accurate (fact-based). 
• Hands on and creative. 
• Self-driven individual. 
• Fluent in English (company language) 

Why Us?

What can we offer to you? 

• Unique opportunity to join an early-stage company with the possibility to participate in a stock option plan.  
• Competitive salary (according to your experience/skills). 
• Private Health insurance (optional) 
• Training bonus for professional development. 
• In house language classes (optional)  
• 23 vacation days per year + 24th and 31st of December. 
• Fruit and coffee at the office.  
• A collaborative environment.

Please note that this is a 1 year full time position based in Bellaterra. 

#diverseandinclusive 

We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation and identity or any other status  

About Us

We are scientists, doctors, techies and humanity lovers, with the mission of building neuroelectronic interfaces to cure brain disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build safe, uninvasive and highly efficient neural solutions. Our mission is to decode and modulate neural networks to maximize patient time on therapy.  

INBRAIN NEUROELECTRONICS

Please click here to apply.