Quality Assurance Manager for Innovative Medical Devices

Barcelona, Spain          ·           Full time

Quality Assurance Manager for Innovative Medical Devices

• Permanent employee, Full-time
• Barcelona

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

In this position you will play a key role within the organization  overseeing  that  the strategic activities of the company such as design and development, clinical investigations, production and distribution of devices are executed according to the relevant  quality standards and regulations.  You will be responsible for  implementing and maintaining the quality management system (QMS) of Neuroelectrics  and ensuring its effectiveness to meet the company’s needs. As Quality Assurance Manager you will  ensure that the QMS is  compliant with the certification and other regulatory requirements (ISO 13485, MDSAP, FDA QSR, GCPs,…) as defined by the management.

This is an exciting moment to join our growing and dynamic  Regulatory Affairs and Quality Assurance team where you will be able to significatively impact on business processes and contribute to elevate the organization’s quality culture. 

What Will You Do

• Ensure that processes needed for the quality management system are implemented, documented and monitored.
• Ensure that all documentation related to design control, clinical investigations,  production and distribution  is prepared, reviewed, approved, stored and applied as per the QMS requirements.
• Report to top management on the effectiveness of the quality management system and any need for improvement.
• Ensure the promotion of awareness of quality management system requirements throughout the organization.
• Ensure training of the organization in the QMS and its procedures.
• Lead and train the quality team.
• Plan, organize and participate  in internal and external audits and inspections from Competent authorities.
• Plan, organize and participate (or oversee)  in suppliers and clinical audits.
• Oversee and follow-up the status and actions related to change control,  non-nonconformities (NC) and  corrective and preventive actions (CAPA).
• Ensure that customer claims related to medical devices are duly assessed and necessary actions are taken according to the Non-Conformity/CAPA and VIGILANCE procedures.
• Promote and contribute in the development and implementation of quality aspects to ensure that production operations (from supplier qualifications to delivery of the products to clients) are in compliance with cGMP and other regulatory requirements.
• Promote and contribute in the development and implementation of quality aspects to ensure that clinical operations (from set-up to close-out of  clinical investigations) are in compliance with GCPs and other regulatory requirements. 
• Work with all relevant internal stakeholders including production, supply chain, product development/engineering teams, clinical development, regulatory affairs, quality etc…  to ensure compliance and continuous improvement.
• Recommend and implement process improvements to internal activities and procedures as indicated by customer claims, non-conformities, audit observations, new regulations, guidance documents and industry standards.
• Act as Management Representative (in accordance with ISO 13485).

What Do You Need

• At least 5 years of experience in quality with medical devices.
• Experience in maintaining a certified ISO 13485 QMS.
• Experience in quality aspects related to clinical investigations.
• Experience in the planning and handling of Audits (internal, externals, vendors and clinical audits).
• Experience in liaising with Notified bodies.
• Experience with handling NC, CAPA, Change Control, and monitoring of a QMS.
• University degree, in a engineering or life-science discipline.
• Deep knowledge of medical devices quality systems as  ISO 13485, GCPs (ICH GCP E6 and ISO 14155 ) and FDA QSR.
• Familiar with e-QMS software.
• Knowledge of Medical Device Regulations relative to CE mark and FDA premarket submissions.
• Knowledge of medical device development, clinical investigations  and manufacture.
• Familiar with active and software containing medical devices.
• Fluent in English both written and spoken.

You Will Be The Perfect Fit If You Are/Have

• Passionate about making a difference, gifted with a can-do attitude.
• Flexible, problem-solving and pragmatic mindset.
• Ability to provide a solution-based approach to emerging challenges.
• 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.
• 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).
• Flexible Working Hours and Hybrid work.
• Professional development and collaborative environment.
• Fully stocked kitchen (Coffee, organic fruits, snacks, and beverages).
• 26 vacation days per year + 24th and 31th of December.
• Private Health insurance, including dental coverage.
• Unique opportunity to join our company early with excellent market traction and huge potential to grow.
• Incredible office in Av. Tibidabo with stunning views of all of Barcelona.
• 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.