Altoida is a pioneer in developing digital biomarkers of neurological disease using augmented reality and machine learning. Our technology platform is designed to enable an objective evaluation of an individual’s neurological health, allowing for more accurate patient selection and stratification for clinical trials, as well as sensitive monitoring of disease progression. Altoida’s mission is to provide life sciences companies with actionable insights using real-world data to increase the success rate for novel therapeutics, and usher in a new era of precision neurology using digital biomarkers. Our proprietary evidence-based platform is founded on more than 20 years of scientific research and published in multiple peer-reviewed papers including Nature Digital Medicine. For more information, visit www.altoida.com . Follow us on Twitter @altoida.

Altoida’s culture is united around six core principles:

• Patient-First
• Open Communication
• Collaborative
• Reliable
• Embrace Positive Change
• Think and Build at Scale
  
  
  

We are looking for a skilled and motivated Quality Engineer, SaMD reporting to the Head of Quality Management, to join our team on a permanent basis. In this role, you will assist in executing Altoida's Quality Management System activities and play a crucial role in ensuring the safety, reliability, and compliance of our Software as a Medical Device. You will collaborate closely with cross-functional teams, including software developers, regulatory affairs, medical, sales and product management, to ensure the quality of our SaMD throughout its lifecycle and maintenance and improvement of the QMS.

Responsibilities

• Assist in the implementation and continuous improvement of an effective and scalable QMS and quality assurance strategy for SaMD, aligned with regulatory requirements and industry best practices. Identify and develop processes and systems to support Altoida’s growth.
• Ensure devices are conform in accordance with Company quality management system prior to device release;
• Participate in risk management activities, including hazard analysis, risk assessments, and risk mitigation planning to ensure potential risks associated with the SaMD are identified, assessed, and addressed.
• Ensure adherence to relevant regulatory standards and guidelines, such as FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO 13485, IEC 62304, EU MDR and other applicable international standards through QMS activities and oversight.
• Assist in the planning, executing, and overseeing of software verification and validation activities, including test planning, test case development, test execution, and documentation of results to ensure software meets specified requirements and quality standards.
• Generate and maintain accurate and comprehensive quality-related documentation, including design control documents, test plans, protocols, reports, and standard operating procedures (SOPs).
• Ensure Document Control is compliant with QMS and regulations.
• Evaluate and approve change requests related to the SaMD, assessing potential impact on quality, safety, and compliance, and ensuring appropriate verification and validation activities are performed.
• Collaborate with software development teams to identify, investigate, track, and resolve software defects, ensuring timely resolution and effective corrective actions.
• Assist in internal and external audits and inspections related to quality and regulatory compliance, providing necessary documentation, addressing findings, and implementing corrective actions
• Identify opportunities for process improvements and quality enhancements within the SaMD development lifecycle and QMS, driving the implementation of best practices and lessons learned.
• Provide training and guidance to team members and stakeholders on quality assurance principles, and software development processes.
  
  
  

Desired Skills And Experience

• Advanced degree preferred
• Ability to work effectively in a fast-paced, dynamic environment.
• You work independently and proactively.
• You have a positive attitude.
• You are not afraid to voice your opinion.
• You produce positive results in a high-pressure environment.
• You prioritize tasks and complete assignments in a thorough and competent manner.
• You recognize areas to increase efficiency and contribute solutions.
• You have proficient oral and written communication skills and enjoy working in a team environment.
• You get excited about quality and documentation.
  
  
  

Travel is not currently expected for this position.

Compensation

Altoida provides competitive and comprehensive compensation and benefits programs. Specific benefit offerings may vary by location, position, and/or business unit. The full-time salary range is commensurate with experience.

Location

Altoida’s US headquarters is located in Washington, DC. The position is remote.

Equal Opportunity

Altoida does not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Altoida is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process.