Quality Systems Manager
Quality & Regulatory
hybrid: Colorado
Salary range $108,000 - $120,000
added Thu Aug 17, 2023
Apply to RapidAIWe are looking for an experienced Quality Systems Manager to join our team.
What you will do:
- Manage the Quality Management System through writing and updating procedures and documents related to ISO 13485, 21 CFR 280, MDSAP Regulations, and other world-wide regulations and standards.
- Assist with the transition to new standards and regulations by interpreting the regulation, updating procedures, coordinating audits, and supporting technical documentation and clinical evaluation report updates.
- Assist with keeping Supplier Files up to date and implementing Quality Agreement with applicable vendors.
- Maintain all procedures and documents in an organized and readily available fashion for audits.
- Perform other ISO 13485 and 21 CFR 820 related activities as assigned by reporting manager.
- Arrange, sort and store documents, samples, records as needed.
- This position does not have direct reports.
- Perform any other related activities assigned by reporting manager.
What you bring:
- Bachelor’s degree with five (5) plus years of related experience preferred or seven (7) plus years of experience.
- Previous experience working with Document Control Systems and Quality Management Systems, Regulations, and Standards
- Strong organizational and project management skills, with attention to detail and accuracy
- Strong people and communication skills (oral and written).
- Results driven with a focus on 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.
- 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.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $108,000 to $120,000. 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.
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.