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Found 2 Skills
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
Produce a multi-quarter QA strategy document. Covers scope, risk-based prioritization, test levels (unit/integration/E2E), pyramid analysis, entry/exit criteria, quality KPIs, tool selection rationale, CI scaling levers, and timeline planning. Output is an actionable strategy document, not a shelf document. Use when: "test strategy," "QA strategy doc," "testing approach," "QA roadmap," "multi-quarter QA direction." Not for: a single-sprint or single-release plan — use test-planning. Not for: identifying which areas carry the most risk — use risk-based-testing first. Related: risk-based-testing, qa-metrics, release-readiness, test-planning, test-reliability.