MindMaze is the world’s leading neurotechnology start-up pioneering a breakthrough computing platform that captures brain activity upon intent, creating a new operating system for computers (a Mind-OS) and a new generation of brain computer interface products, using virtual reality (VR), augmented reality (AR) and A.I. Based on a decade of rigorous testing in the healthcare industry, the company has designed intuitive mind/machine interfaces, which utilize pre real-time decoding of brain signals and is able to track fine movements and gestures. Its innovations are poised to transform industries, starting with healthcare and gaming.  Its first-generation products (MINDMOTION™ Pro and MINDMOTION™ Go) are aimed at rehabilitation following neurological incidents.

Join our eclectic mix of scientists, physicists, engineers, and clinicians to help change the world!

As MindMaze’s Senior Quality Engineer you will join our Quality Assurance and Regulatory Affairs team and will be responsible for ensuring MindMaze’s overall product and company compliance. To do this you will create and pilot continuous improvement projects and participate in the performance of routine quality system functions in close collaboration with cross-functional team members (Software developers, Engineering, Sales & marketing, Regulatory Affairs, Clinical & Scientific, Supply Chain etc.).

Being part of a small team in a scale-up environment such as MindMaze implies that you will be given the opportunity to share your experience to support company growth.

You will:

• Research emerging quality and regulatory trends and changes in regulations and standards to incorporate them into the business to ensure ongoing compliance to these requirements;
• Monitor, analyze and identify trends from quality and performance data, proactively developing performance improvement measures;
• Evaluate and optimize existing processes and systems and design and implement new ones when necessary;
• Provide Guidance on the creation and maintenance product-design and risk-management files following relevant quality system and regulatory requirements, and risk management and process development best practices;
• Define and Execute manufacturing processes validation activities required for Mindmaze device portfolio;
• Maintain and improve the Computerized Systems Validation process, ensuring that the corporate Computerized Systems are fit-for-use and compliant;
• Develop and maintain MindMaze’s internal audit program to ensure compliance of the quality management system; conduct and manage audits, support inspection readiness and external inspections, develop metrics and compile data on auditing results, issues or trends and corrective actions;
• Inspect and release production material, components, and finished products;
• Perform detailed Root Cause Investigation of failed products or processes using various quality tools and manage the disposal of non-conforming material when required;
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line;
• Process product complaints in a uniform and timely manner up to the approval Product Evaluation Reports and complaints for final closure as applicable. Direct urgent issues to the proper personnel for reportability decisions;
• Ensure quality issues are managed according to the procedure and ensure adequate corrective/preventive actions are effective to eliminate/mitigate the issue;
• Manage and maintain organization of all quality documents at Mindmaze;
• Direct or conduct personnel training on FDA, ISO, and audit requirements;
• Promote and nurture the highest standards of professionalism, ethics, and compliance, and actively support our compliance program-related initiatives and activities.

Essential skills:

• Minimum Bachelor’s degree, preferably in Engineering, or a scientific field, or equivalent;
• 8 to 10 years Quality Assurance/Quality Control experience in the medical device and/or pharmaceutical/highly regulated industry;
• Experience in a FDA regulated industry and ISO 13485 certified organization;
• Strong knowledge of the European, Canadian and USA Regulations and the associated relevant standards applicable to medical devices, including Risk Management, Usability, Electrical safety, and Medical Software Validation;
• Experience directly performing audits in the medical device and/or highly regulated industry;
• Experience with manufacturing processes and computerized systems validation and related functions;
• Experience managing Quality Management System elements such as CAPA, Complaints, Internal audit, Document Management, etc.;
• Familiar with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly;
• Fluent in English or French with Minimum B2 level in the other language;
• Willingness to travel up to 20% of the time.

Icing on the cake:

•  General understanding of applied Statistical Methodologies;
• Experience with Six Sigma tools and applications;
• CQA (Certified Quality Auditor) is desirable;
• Prior exposure to a Holocratic organisation.

To be successful you can illustrate the fact that you have the following abilities:

• Service orientation with recognized mentoring skills and an ability to adapt communication style to a wide variety of audiences;
• Ability to build constructive work relationships and at ease with interacting with colleagues at all hierarchical levels;
• Extremely well organized, with a strong focus on detail, and the ability to set levels of detail-orientation that you require colleagues to meet;
• Ability to demonstrate initiative and to solve problems in a fast-paced, ever-changing business environment. Displaying a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross-functional problems;
• Ability to work with minimal supervision and to make decisions even if provided with limited information;
• A good sense of humor and at ease working both autonomously and as being part of a team.

Do NOT apply if:

• You do not thrive working with engineers and R&D teams;
• Innovation and a lack of clear precedents make you nervous;
• You’re seeking a springboard to a new job within the next year.