Overview
Quality Manager – MI Jobs in Ann Arbor, MI at CRP Industries Inc
Medical Device Regulatory, Quality, and Test Lead
At EchoTech.ai, we are reinventing powered wheelchair mobility with Magic Mode—an AI co-pilot that handles steering and speed control so disabled users can focus on living, not just driving. By harnessing the power of advanced end-to-end AI, we give handicap people newfound confidence and freedom while keeping them firmly in control—choosing their destination and route along the way. From individuals who rely on head arrays or sip-and-puff devices to anyone seeking smoother navigation, Magic Mode reduces the daily strain of precise driving with a smart “cruise control”. And this is just the beginning—our work is paving the way for fully autonomous powered wheelchairs, transforming what is possible for those who need it most.
We are looking to fulfill a new position for an FDA Medical Device Regulatory, Quality and Testing Lead. This person will coordinate directly with our FDA consultants where we are going through the process to become certified as a Class II Medical Device. This person will work closely with our engineering team to conduct tests on our powered wheelchair required by the FDA to ensure user safety. Long term this position will ensure compliance with FDA and ISO requirements and test our wheelchairs to provide user safety.
Responsibilities:
FDA Certification: Lead the process for Class II device clearance, including preparation of regulatory submissions.
Collaboration: Act as the liaison between internal teams and external FDA regulatory consultants, ensuring all processes meet FDA standards.
Documentation: Create and maintain detailed records for regulatory audits and submissions.
Quality Management: Develop and maintain a QMS aligned with ISO standards.
Risk & Testing: Oversee risk management and testing to ensure product safety and regulatory compliance.
Archive and manage all test data.
Coordinate with our wheelchair manufacturer partners to leverage off of their test procedures when they obtained a Class II Medical device certification.
Develop installation of Magic Mode kit procedures and assembly processes.
Preferred Skills:
· Bachelor’s degree in Engineering or Quality
Experience in regulatory compliance or quality assurance with medical devices.
Familiarity with ISO 13485 (QMS), ISO 14971 (risk management), and ISO 7176 (Powered Wheelchair Testing)
Excellent technical writing, analytical, and communication skills.
Please forward your resume’ to:
Bill Bastian
EchoTech.ai
525 S. Meridian Street
Indianapolis, Indiana 46225
www.EchoTech.ai
www.MagicMode.com
EchoTech.ai is a start-up company that develops vision-based AI guidance systems to enable autonomy and independence for people who use powered wheelchairs. We offer a wide variety of interfaces: joystick, gesture, voice, external controller, etc. to provide parent commands to the wheelchair for semi-autonomous and autonomous wheelchair movement. We call our product “Magic Mode”.
Job Type: Full-time
Pay: $62,000.00 – $77,000.00 per year
Benefits:
401(k)
Health insurance
Paid time off
Schedule:
8 hour shift
Day shift
Monday to Friday
Ability to Commute:
Indianapolis, IN 46225 (Required)
Ability to Relocate:
Indianapolis, IN 46225: Relocate before starting work (Required)
Work Location: In person
Title: Quality Manager – MI
Company: CRP Industries Inc
Location: Ann Arbor, MI
