Agent skill · product strategy · borghei
quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality objectives and KPIs, quality culture, and Notified Body / FDA inspection prep per ISO 13485 Clause 5.5.2.
Why this skill is useful
Provides detailed workflows and accountability structures for quality management in HealthTech and MedTech, which the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
Senior Quality Manager Responsible Person (QMR) Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements. --- QMR Responsibilities ISO 13485 Clause 5.5.2 Requirements Responsibility Scope Evidence ---------------- ------- ---------- QMS effectiveness Monitor system performance and suitability Management review records Reporting to management Communicate QMS performance to top management Quality reports, dashboards Quality awareness Promote regulatory and quality requirements Training records, communications Liaison with external parties Interface with regulators, Notified Bodies Meeting records, correspondence QMR Accountability Matrix Domain Accountable For Reports To Frequency -------- ----------------- ------------ ----------- Quality Policy Policy adequacy and communication CEO/Board Annual review Quality Objectives Objective achievement and relevance Executive Team Quarterly QMS Performance System effectiveness metrics Management Monthly Regulatory Compliance Compliance status across jurisdictions CEO Quarterly Audit Program Audit schedule completion, findings closure Management Per audit CAPA Oversight CAPA effectiveness and timeliness Executive Team Monthly Authority Boundaries Decision Type QMR Authority Escalation Required --------------- --------------- --------------------- Process changes within QMS Approve with owner Major process redesign Document approval Final QA approval Policy-level changes Nonconformity disposition Accept/reject with MRB Product release decisions Supplier quality actions Quality holds, audits Supplier termination Audit scheduling Adjust internal audit schedule External audit timing Training requirements Define quality training needs Organization-wide training budget --- Clarify First Before preparing a quality artifact, confirm these inputs. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/quality-manager-qmr