Quality Management Systems Specialist

Accountabilities:: Own the end-to-end lifecycle of corrective and preventive actions (CAPAs) and nonconformance reports (NCRs), including initiation, root cause investigation, action planning, implementation tracking, and effectiveness verification. Manage the active CAPA/NCR queue, providing regular visibility into status, risks, blockers, and timelines during weekly quality meetings. Partner with Engineering and other functions to ensure remediation activities are completed on time and documented in accordance with QMS requirements. Manage the complete document control lifecycle within the QMS platform, including authoring, review routing, approvals, release, and periodic reviews. Coordinate change events from initiation through closure, ensuring appropriate cross-functional input and regulatory traceability. Draft, update, and maintain SOPs, work instructions, and policies in alignment with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements. Serve as the Quality representative within the software release process, participating in go/no-go reviews and confirming QMS requirements are met before release sign-off. Own release documentation packages, ensuring change events, risk register updates, usability files, design history file entries, and required regulatory notifications are complete and properly linked. Coordinate with Engineering, Regulatory, and Clinical Affairs to identify quality-relevant software changes and determine appropriate documentation requirements. Maintain and improve release sign-off workflows within the QMS platform, ensuring traceability between software changes and quality records. Coordinate internal QMS audits, track findings, and ensure corrective actions are followed through to completion. Support third-party and certification body audits, including MDSAP and ISO/MDR audits, by preparing documentation packages and responding to findings. Monitor regulatory developments and identify changes that may affect QMS compliance requirements. Oversee complaint-handling compliance by maintaining relevant SOPs and work instructions, monitoring adherence, escalating systemic issues, and providing guidance on complaint classification. Coordinate periodic complaint data reviews to identify quality signals that may require CAPA or post-market surveillance consideration. Administer QMS training activities, track completion, follow up on outstanding assignments, and support companywide training campaigns through walkthroughs and guidance materials. Evaluate and support the adoption of new QMS capabilities, including tools related to SBOM management, vulnerability tracking, and dependency management. Requirements 3–5 years of QMS experience within a regulated medical device or Software as a Medical Device (SaMD) environment. Hands-on knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements. Experience with EU MDR and/or Health Canada regulatory requirements is a plus. Direct experience managing CAPAs, NCRs, and change events through a QMS platform; experience with Qualio is strongly preferred. Experience participating in software release processes in a Quality capacity, with the ability to connect software changes to QMS documentation and compliance requirements. Strong organizational skills and the ability to manage multiple active compliance items while maintaining visibility into deadlines, risks, and documentation requirements. Strong written communication skills, including the ability to create clear SOPs, root cause analyses, training materials, and companywide communications. Detail-oriented approach with a strong commitment to accuracy, traceability, documentation quality, and timely execution. Collaborative, low-ego working style with the ability to build effective relationships across Engineering, Clinical Affairs, Regulatory, and other functions. Experience supporting MDSAP renewal audits and responding to certification body findings is a plus. Familiarity with SaMD-specific quality practices, including software validation, algorithm change protocols, and IEC 62304, is a plus. Experience evaluating or implementing modern QMS platforms beyond traditional document management systems is a plus. Background in post-market surveillance and complaint trend analysis for AI-powered medical devices is a plus. Benefits Full-time, remote position based in the United States. Competitive compensation and benefits offerings. Flexible, unaccrued paid time off (PTO). Ongoing training and professional development opportunities. Remote-first work environment. Opportunity to contribute to quality systems supporting regulated medical software and AI-enabled healthcare technology.