Senior Quality Systems Specialist

Company Overview: 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 FieldForce Ablation System is a focal, contact-sensing PFA system built on proprietary FieldBending™ 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 FieldForce system is designed to enable targeted and tailored ablation treatment while platform features focus on procedural efficiency. About the Role: We are seeking an experienced Senior Quality Systems Specialist to join our growing medical device company. This position is the cornerstone of our quality management infrastructure, responsible for owning the document control lifecycle and device deficiency process in support of our ongoing clinical trials. The ideal candidate brings deep expertise in controlled document management and investigational device event handling with a collaborative approach to quality operations in a fast start-up environment. Core Responsibilities: Document Control Own and administer the end-to-end document control system, including authoring, review, approval, version control, distribution, and archival of all controlled documents Serve as the primary 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 Maintain the quality management system (QMS) document hierarchy, ensuring accessibility, accuracy, and traceability of all records Lead training coordination for new and revised documents, tracking employee acknowledgment and completion Administer and continuously improve the electronic document management system (e.g., Grand Avenue Software) Device Deficiency Handling Own and manage the end-to-end 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 all records are complete, accurate, traceable to specific clinical trial events, and audit-ready for FDA, IRB, or sponsor reviews Generate 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 Partner 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 Additional Quality Responsibilities: 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 Required Qualifications: Bachelor's degree in Life Sciences, Engineering, or related field 7+ years of quality assurance experience in a medical device manufacturing environment Demonstrated expertise in document control systems and controlled document lifecycle management In-depth experience with 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 quality management software systems Self-motivated with strong organizational and time management skills within a hybrid environment. Strong written communication skills with meticulous attention to detail in documentation Team player with the ability to work collaboratively across departments Preferred Qualifications: Experience in a startup or early-stage medical device company Familiarity with pulsed field ablation or cardiac electrophysiology device products ASQ Certified Quality Engineer (CQE) or equivalent certification Location & Travel Requirements: Hybrid with availability for remote work Field Medical, Inc. is proud to be an equal opportunity employer. We are committed to creating an inclusive and respectful workplace where everyone has the opportunity to thrive. All employment decisions, including recruitment, hiring, assignments, promotions, compensation, and other aspects of employment, are made without regard to race, color, religion, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or any other protected status. At Field Medical, we believe that diverse perspectives fuel innovation and we’re proud to foster a culture where all voices are valued.

Created: 2026-03-12