Vp, Quality Assurance

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.

The Vice President, Quality Assurance is a key leadership role responsible for developing, implementing, and maintaining the quality management system to ensure the highest level of product quality and regulatory compliance. This role involves leading the Quality Assurance function, a team of quality professionals, defining quality standards, and collaborating across departments to achieve organizational goals, establishing quality processes and monitoring metrics for compliance. This role involves overseeing the quality management system, quality compliance, process improvement, and quality control initiatives meeting all worldwide markets. 

What you will do:

• Quality Management System (QMS) Leadership:
• Monitor, implement changes, and maintain the organization's QMS to meet quality objectives and requirements worldwide.
• Establish and monitor key performance indicators (KPIs) to measure the effectiveness of the QMS.
• Manage the core quality system activities and deliverables to maintain compliance to international medical device regulations and certifications.
• Formulate, write and maintain procedures, specifications and standards for the quality control of ISV products to ISO 13485, MDR and 21 CFR 820.
• Maintain training system records and processes for the QMS required training.
• Maintain supplier management records and files.
• Provide guidance to employees on quality system quality regulation requirements.
• Maintain the defect management records and processes.


Regulatory Compliance:
• Stay current with relevant industry regulations and standards.
• Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.


Quality Assurance Strategy:
• Stay current with relevant industry regulations and standards.
• Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.


Regulatory Compliance:


• Stay current with relevant industry regulations and standards.
• Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.


Quality Assurance Strategy:


• Develop and execute a comprehensive Quality Assurance strategy aligned with the organization's goals and objectives.
• Identify and mitigate quality risks across the organization.


Team Management:


• Recruit, train, and mentor a high-performing team of quality professionals.
• Set performance expectations, conduct regular performance reviews, and promote professional development.


Quality Control:


• Implement effective quality control processes and methodologies to monitor product or service quality.
• Lead investigations and root cause analyses for quality issues and implement corrective and preventive actions (CAPAs).


Process Improvement:


• Continuously assess and improve quality-related processes and procedures.
• Collaborate with cross-functional teams to optimize workflows and enhance product or service quality.


Documentation and Reporting:


• Maintain accurate and comprehensive quality documentation, including records of audits, inspections, and quality reports.
• Prepare and present quality-related reports to senior management.


Stakeholder Communication:


• Effectively communicate quality-related information to internal and external stakeholders, including customers, regulatory agencies, and auditors.

What you will do:

• Bachelor's degree, preferably in engineering or related discipline. A master's degree is often preferred.
• 15+ years experience in Quality Assurance and regulatory compliance, with a track record of progressively increasing responsibility.
• 15+ years  in progressive Medical Device Quality roles including management of ISO 13485, MDR and 21 CFR 820 QMS.
• Experience in SaMD/SaaS product based companies
• Experience in dealing with representatives from the Food and Drug Administration (FDA) or other auditing/inspection agencies.
• Previous experience in FDA and Notified Body interactions including FDA inspections, MDSAP Audits, ISO Audits, etc.
• Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.).
• Experience in software engineering practices for SaaS and SaMD products.
• 10 years of people management experience.
• Strong knowledge of industry-specific regulations and standards.
• Excellent leadership and team management skills.
• Effective communication and interpersonal skills.
• Analytical thinking and problem-solving abilities.

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!

Compensation - The salary range target for the role described in this job description is $200,000 to $245,000. 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.

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