Manager, Quality Engineer Jobs

RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering 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, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible. RapidAI – where AI meets patient care.

What you will do:

• Review product requirements for traceability, risk remediation and testability.
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Perform design control and risk management activities according to RapidAI’s Quality System.
• Support the development, update, validation, and documentation of software utilized in the testing of SaMD.
• Independently perform quality engineering activities related to Software as a Medical Device (SaMD).
• Apply knowledge of global regulations and guidance's. Assist in the preparation for and support of regulatory agency and internal audits.
• Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.
• Track software problem reports and deviation up to closure.
• Review verification and validation deliverables for compliance with regulatory requirements.
• Develop, implement, and maintain standards for software quality processes, systems, and procedures to support the software life cycle.

What you bring:

• Results driven: Focused on individual and team success by being accountable to strict deadlines and holding collaborators accountable.
• Strong organizational and project management skills with an attention to detail and accuracy
• Strong people and communication skills (oral and written).
• Previous experience executing to IEC 62304 in regard to SaMD is preferred.
• Previous experience working with Quality Management System (ISO 13485 and 21 CFR 820) is preferred.
• Strong work ethic and interpersonal skills.
• Bachelor of Science Degree with 8+ years of experience preferred.

What we offer you:

• We pay 100% for Short and Long Term Disability.
• And most importantly - You are joining an awesome team!
• Healthcare and Dependent care flexible spending accounts are available
• Incentive Compensation
• RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
• Equity - Stock Options
• We have 10 company paid holidays!
• A 401k plan is offered through Empower
• RapidAI provides $100 a month for internet/cell/phone services.
• 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

Compensation - The salary range target for the role described in this job description is $105,000 to $120,00. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.

RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.