Quality Engineering Manager
2 weeks ago
RapidAI is a global leader in using AI to combat life-threatening vascular and neurovascular conditions. Our mission is to empower physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow.
Based on intelligence gained from over 10 million scans in more than 2,000 hospitals in over 60 countries, our Rapid platform transforms care coordination, offering care teams a level of patient visibility never before possible.
We are seeking an experienced Quality Engineer to independently lead quality engineering activities at RapidAI.
In this role, you will develop and maintain cutting-edge quality processes, ensuring compliance with global regulations while partnering with technical teams to manage risk and drive continuous improvement across the software lifecycle.
Key Responsibilities:- Independently perform quality engineering activities related to Software as a Medical Device (SaMD).
- Develop, implement, and maintain standards for software quality processes, systems, and procedures to support the software life cycle.
- Perform design control and risk management activities according to RapidAI's Quality System.
- Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.
- Review product requirements for traceability, risk remediation, and testability.
- Review verification and validation deliverables for compliance with regulatory requirements.
- Track software problem reports and deviation up to closure.
- Support the development, update, validation, and documentation of software utilized in the testing of SaMD.
- Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
- Apply knowledge of global regulations and guidance's. Assist in the preparation for and support of regulatory agency and internal audits.
- Bachelor of Science Degree with 8+ years of experience preferred.
- Previous experience working with Quality Management System (ISO 13485 and 21 CFR 820) is preferred.
- Previous experience executing to IEC 62304 in regard to SaMD is preferred.
- Strong organizational and project management skills with an attention to detail and accuracy.
- Strong people and communication skills (oral and written).
- Strong work ethic and interpersonal skills.
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits - We offer a range of policies through TriNet.
- Life Insurance/AD&D is 1X times your annual salary.
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available.
- A 401k plan is offered through Empower.
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 11 company paid holidays.
- RapidAI has a flexible vacation policy. We urge employees to take vacation to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options.
- Incentive Compensation.
- And most importantly - You are joining an awesome team.
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