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!