Quality Assurance Specialist

About the role

Carlsmed is seeking a Quality Assurance Specialist to support its personalized spine surgery platform. The role focuses on ensuring regulatory compliance and quality performance across proprietary implants, instrumentation, and design automation systems.

Key responsibilities

• Plan and lead CAPA meetings, document minutes, and drive actions.
• Manage CAPA records in an electronic system, tracking due dates and workflow approvals.
• Conduct root‑cause analysis sessions and develop corrective action plans with subject‑matter experts.
• Assess audit findings, prioritize corrective actions, and schedule annual internal audits.
• Perform audits, evaluate evidence for conformity, and produce audit reports.
• Support customer and regulatory audits, handling logistics, documentation, and follow‑up.
• Interpret industry standards and regulatory changes, perform gap analyses, and update corporate procedures.
• Lead process‑improvement projects to streamline quality practices.
• Manage field actions, including customer notifications and product documentation.
• Analyze and trend quality metrics using pivot tables, charts, and graphs, and present findings to management.

Required profile

• Lead Auditor certification (ISO 13485) preferred.
• Strong background in quality management systems and regulatory compliance.
• Experience planning and executing internal and external audits.
• Ability to work independently and coordinate cross‑functional teams.

Required skills

• CAPA management software proficiency.
• Electronic QMS (eQMS) system usage.
• Advanced Microsoft Excel skills (pivot tables, charts, graphs).
• Audit planning and documentation tools.