Quality Systems Specialist

QUALITY SYSTEMS & DOCUMENTATION SPECIALIST Looking to join a cutting edge medical device team paving the way in a very unique product line? The Quality Systems & Document Control Specialist is the central steward of our Quality Management System and a key partner across engineering, operations, clinical, and commercial teams. This role ensures that our Class III devices are developed, manufactured, and supported in full compliance with FDA, ISO 13485, and global regulatory expectations. You’ll own the systems, processes, and documentation that keep our company running smoothly—while bringing a friendly, service-oriented approach to helping teams get things done right. Key Responsibilities Quality Management System Ownership — Maintain, improve, and implement QMS processes, procedures, work instructions, and forms across the organization. Document Control Leadership — Manage all document control activities, including routing, approval, release, archival, and version control. Electronic QMS Administration — Serve as system owner for ETQ (previously SharePoint), ensuring configuration, user support, and data integrity. Change Control Management — Lead change control workflows, ensuring timely, compliant execution and cross-functional alignment. Design History File Oversight — Maintain complete, accurate DHF documentation for all active implantable device programs. Supplier Quality File Processing — Manage supplier documentation, qualification records, and ongoing compliance files. Training Program Coordination — Maintain training matrices, track completion, and support onboarding for quality-related processes. Nonconformance & CAPA Monitoring — Support and track NCs, complaints, investigations, and CAPAs; ensure timely closure and robust documentation. Quality Metrics & Reporting — Generate dashboards and reports for leadership, audits, and management reviews. Customer Feedback Follow-Up — Track, route, and support resolution of customer feedback and complaint-related inquiries. Product Release Support — Verify documentation, ensure QMS compliance, and support release readiness activities. Data Reconciliation — Confirm alignment between local systems and cloud-based company data repositories. Cross-Functional Collaboration — Partner with engineering, operations, clinical, and sales teams to ensure quality processes are understood and followed. What You Bring Experience supporting Class III medical devices. 5+ years in Quality Systems, Document Control, or Quality Engineering. Hands‑on experience with eQMS platforms (ETQ preferred; SharePoint experience a plus). Strong understanding of FDA 21 CFR 820, ISO 13485, ISO 14971, and global regulatory expectations. Excellent communication skills and a customer-service mindset—you enjoy helping teams succeed. Detail-oriented, organized, and comfortable managing multiple priorities. A collaborative, friendly approach that fits a tight‑knit startup culture. Ability to work onsite in San Diego Tuesday–Thursday. For immediate consideration, please send your resume to View email address on click.appcast.io! #J-18808-Ljbffr