Stereotaxis · 9 hours ago
Quality Specialist
Stereotaxis - St. Louis, MO 63101 US (Primary)
Full-time
Onsite
Entry, Mid Level
1+ years expStereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. The Quality Specialist is responsible for ensuring compliance with US and International Quality System requirements, focusing on sustaining Quality Management System processes, process improvement, quality control inspections, and document control.
BiotechnologyHealth CareMedical DeviceNavigation
No H1B
Responsibilities
Act as Quality representative on continuous improvement teams to ensure compliance with Regulations, International Standards, and internal QMS system requirements
Assist with complaint handling processes, nonconformance/deviation processes, field return processes, audit management, and perform corrective and preventive action activities
Guide QMS sustaining activities through active completion of Standard Operation Procedure and Work Instruction expectations
Support document control functions of change control by ensuring that records are readily available, properly defined, categorized, maintained, and implemented according to the document type
Perform DHR review/release of sterile and non-sterile products
Perform visual and/or document review/release of component products
Coordinate the reporting/analysis of quality data and resolution of material and product quality issues
Improve process quality by making recommendations for change while working with relevant teams and departments to improve processes
Ensure processes adhere to company and industry quality standards
Drive continuous improvements in all areas, focusing on key performance indicators
Support data collection and analysis for reporting on key performance indicators
Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements
Conduct internal audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
Qualification
Required
Excellent written and verbal communication skills
Excellent organizational skills and detail oriented
Legally authorized to work in the United States
Preferred
B.S. Degree in a Science or Engineering field highly preferred and/ or business experience
1-3 years' experience in regulated medical device industry highly preferred
Strong knowledge of global Quality System regulations in an ISO 13485 or ISO 9001 compliant facility highly preferred
Experience with electronic quality system documentation management highly preferred
Company
Stereotaxis
Stereotaxis develops robotic cardiology instrument navigation systems that enhances the treatment of arrhythmias and coronary diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$166.5MKey Investors
ROTH Capital PartnersRedmile Group
2025-08-29Post Ipo Equity· $50M
2025-07-17Post Ipo Equity· $8.5M
2024-08-15Post Ipo Equity· $3M
Leadership Team
David Leo Fischel
Chairman & CEO
Kim Peery
Chief Financial Officer
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-09
BioWorld Financial Watch
2026-01-07
Medical Device Network
2026-01-07
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