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.