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About Methinks

Methinks vision is to provide universal and timely diagnosis for life-saving treatments worldwide. Our first focus is on stroke, the second cause of death and a major cause of disability in the world. Our product is an artificial intelligence medical imaging software capable of performing stroke triage and unlock stroke treatments potential from non-contrast CTs.

Methinks is a VC backed digital health start-up that recently won the prestigious EIC Accelerator of the European Commission and has obtained two gold medals in the RSNA Kaggle competitions. The recent funding of the company will allow us to grow rapidly and we are looking for exceptional and passionate individuals to help us face these challenges and build together a unique company.

Job Summary

We are seeking a Quality Assurance Specialist who can be part of the Quality and Regulatory Team and ensure compliance with the standards and regulations for the design, development and maintenance of medical devices, more specifically software as a medical device.

This contributor will have a key role in the organization providing support in ensuring that the quality and regulatory requirements are met and products are available in different markets.  

Equal Employment Opportunity

We proudly pursue a diverse workforce and we do not make any hiring or employment decisions that could be discriminatory in any way. We have implemented a gender balance and diversity policy.

Duties and Responsibilities

  • Implementing and maintaining the compliance of the QMS according to ISO 13485, EU MDR 2017/745 and 21 CFR Part 820.
  • Creating and improving lean QMS documentation for software as a medical device.
  • Ensuring compliance with software development lifecycle requirements, policies and procedures (IEC 62304).
  • Performing design control and risk management activities IEC 62304 and ISO 14971).
  • Giving support in the creation of regulatory submission documentation (EU and US).
  • Identifying gaps and improvement opportunities of the Quality Management System.
  • Actively lead and participate in the development, resolving quality issues, and taking corrective and preventative actions (e.g. CAPAs, supplier evaluation, training, management review, etc.).
  • Assist in internal and external audits.
  • Preparing and participating in the submissions to the Spanish Competent Authority (AEMPS).

Skills and Qualifications

  • Preferably 1 year of experience working in Quality Assurance of Medical Devices, preferably in the development of Software as a Medical Device.
  • Bachelor’s degree in science / engineering / technical or other scientific discipline.
  • Understanding of medical device regulations and standards (such as ISO 13485, EU MDR 2017/745, IEC 62304, 21 CFR Part 820, ISO 14971, among others).
  • Experience/interest in Cybersecurity requirements for medical devices (US and EU).
  • Experience/interest in GDPR and HIPAA requirements.
  • Great communication, presentation and interpersonal skills.
  • Business fluent in English.

What can we offer

  • Opportunity to manage and drive the clinical strategy of an award winning Digital Health Start-Up.
  • Be part of a solid experienced team, passionate about their work and capable to bring cutting-edge technology to market.
  • Chance to grow alongside extraordinary individuals at the company growth pace.
  • Combine remote work with working together in our great offices in front of the Port Vell, at Pier01 Barcelona Tech City.
  • Competitive compensation package.

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