Quality Assurance Specialist (Medical Devices)

Regulatory Affairs & Quality Assurance         ·          Barcelona, Spain      ·        Full time 

Who We Are

Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.

We are looking for new members of our team who already live by our shared values and are inspired by our company’s Vision. Accelerate the evolution of brain science and technology by delivering advanced solutions to help end patients suffering from brain pathologies; and our Mission. Revolutionize the understanding of the brain through new personalized neuromodulation therapies, anywhere and at any time.

Position Summary

The Quality Assurance ​Specialist will ​support all QMS maintenance activities, participates in the development and implementation of procedures and other quality-related documentation

What Will You Do

• Provides support in all QMS maintenance-related activities: ( Document control, Non-conformities CAPA, Audits, Inspections,…) 
• Participates in preparing and reviewing procedures, work instructions, forms, specifications, inspections, validation, qualification plans, etc. 
• Work on identifying and documenting product-related complaints, non-conformities, and development of CAPA plan with internal and external stakeholders.
• Support the collection, analyzing, trending, and reporting of quality metrics. 
• Participate in external and internal audits and regulatory authorities’ inspections.  
• Support in Risk management activities (PFMEA).
• Comply with and enforce compliance with established information security and privacy policies and standards and act in accordance with instructions and procedures received

What Do You Need

Must-have

• Degree in Pharmacy, Engineering, or related technical field.
• 2 years experience in Quality in a medical device.
• Knowledge of Quality Assurance tasks (e.g., Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record Review, Documentation management, Training, Supplier Management, validations, qualifications, and calibrations).
• Deep knowledge of quality standards ISO 13485 and FDA 21 CFR 820.
  Familiar with Medical Device Regulations relative to the CE mark (MDR 2017/745) and FDA medical device regulations.
• Knowledge of validations Risk Assessment.
• Fluency in English, both written and spoken.

Bonus-points

• Familiar with active and software containing medical devices.

You Will Be The Perfect Fit If You Are/Have

• Passionate about making a difference, gifted with a can-do attitude.
• Reliable, Responsible, and Respectful.  

• Good communication and presentation skills. 
• Ability to adapt and work effectively within a rapidly changing and growing environment.
• Entrepreneurial spirit with the hunger to succeed; act with a founder’s mindset: have urgency, grit, be adaptable to change, and push boundaries.
• Team player, collaborative, innovative, get things done mind.
• Show initiative in setting and meeting goals within an environment of managed change.
• Ability to work under pressure, responsible for multiple vital tasks in parallel
• Commitment to quality.

If You Join Us, You Will Enjoy:

• Competitive salary in the sector (according to your experience/skills).
• 26 vacation days per year + 24th and 31th of December
• Fully stocked kitchen (Coffee, organic fruits, snacks, and beverages).
• Flexible Working Hours
• Hybrid work.
• Private Health insurance, including dental coverage.
• Professional development and collaborative environment.
• Unique opportunity to join our company early with excellent market traction and huge potential to grow
• Incredible office in Barcelona in Av. Tibidabo. (shower, stunning views of all of Barcelona, etc.) 
• Team Building Events.
• Much more still to come.

About Us

Neuroelectrics is a creative, high-tech company offering the best-in-class non-invasive and high-definition electrical brain stimulation technology for personalized neuromodulation. By measuring and modifying brain function, we aim to restore brain health, minimize disabilities and create a better life for patients.

Please click here to apply.