What you will do:

• 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.

What you bring:

• 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.
• Results driven: Focused on individual and team success by being accountable to strict deadlines and holding collaborators accountable.

What we offer you:

• 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.
Time Off:
• We have 10 company paid holidays!
• RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
Other Cool Benefits:
• Equity - Stock Options
• Incentive Compensation
• And most importantly - You are joining an awesome team!