Quality Specialist

Job Description

Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.

Position Summary:
The Quality Specialist is responsible for ensuring compliance with the US and International Quality System requirements. Areas of focus are sustaining Quality Management System (QMS) processes, process improvement, quality control inspections, and document control.

Essential 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.

Job Requirements

Qualifications & Skills:
•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.
•Excellent written and verbal communication skills.
•Excellent organizational skills and detail oriented
•Legally authorized to work in the United States.

Work Conditions:
This role is an in-office position at Stereotaxis’ headquarters.

Culture:
Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.