Quality Specialist

Founded in 2022, Field Medical Inc. is a medical device company advancing next-generation pulsed field ablation (PFA) technologies for the treatment of cardiac arrhythmias.

The Field Force Ablation System is a focal, contact-sensing PFA system built on proprietary Field Bending™ technology to deliver targeted, high-intensity electric fields using a novel pulsed energy delivery strategy. Designed to support both atrial and ventricular ablation, the system serves as a universal ablation platform for the heart and beyond. The Field Force system is designed to enable targeted and tailored ablation treatment while platform features focus on procedural efficiency.

We are seeking a Quality Specialist to join our growing medical device company. This position plays an important role in our quality management operations, primarily supporting document control processes and device deficiency tracking in connection with our ongoing clinical trials. The ideal candidate has experience in controlled document management and investigational device events, and is eager to develop their skills in a collaborative, fast-paced start-up environment.

• Aid in the end-to-end administration of the document control system, including authoring, review, approval, version control, distribution, and archival of all controlled documents
• Serve as a point of contact and subject matter expert for document control processes, ensuring all documentation meets regulatory and quality standards
• Manage document change control workflows, coordinating cross-functional reviews and approvals to ensure timely and compliant updates
• Help in the maintenance of the quality management system (QMS) document hierarchy, ensuring accessibility, accuracy, and traceability of all records
• Coordinate training for new and revised documents, tracking employee acknowledgment and completion
• Administer and continuously improve the electronic document management system (e.g., Grand Avenue Software)

• Support the device deficiency process for investigational devices used in clinical trials, ensuring compliance with FDA 21 CFR Part 812, ISO 14155, and applicable QMS requirements from intake through closure
• Maintain the device deficiency register, ensuring records are complete, accurate, traceable to specific clinical trial events, and audit-ready for FDA, IRB, or sponsor reviews
• Assist in generating periodic device deficiency trend reports and present findings to quality and clinical leadership, identifying signals, systemic issues, and opportunities for device or process improvement ahead of commercial launch
• Collaborate with Clinical Affairs, Regulatory Affairs, and Engineering teams to investigate device deficiencies, communicate findings to clinical sites as appropriate, and implement sustainable corrective actions that support trial integrity and patient safety

• Draft, revise, and maintain Standard Operating Procedures (SOPs), work instructions, forms, and other controlled documentation in compliance with ISO 13485 and FDA 21 CFR Part 820
• Maintain and improve quality management system (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820
• Support internal and external audits (ISO 13485, FDA), including document preparation, participation, and timely response to findings as needed
• Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement initiatives
• Manage quality metrics and prepare management review reports with trend analysis

• Bachelor's degree in Life Sciences, Engineering, or related field
• 2+ years of quality assurance experience in a medical device manufacturing environment
• Demonstrated experience in document control systems and controlled document lifecycle management
• Knowledge of device deficiency handling, investigational device event Reportability (21 CFR Part 812, IDE Safety Reports, UADEs) in a clinical trial or pre-commercial setting
• Hands-on experience with ISO 13485 quality management systems
• Experience with risk management tools (FMEA, FTA)
• Familiarity with Grand Avenue or similar…