🦴 Director of Quality | Orthopedic Medical Devices📍 North Florida (Relocation Supported) Our client an orthopedic manufacturer is rebuilding its Quality Engineering function, and it needs a leader who will build it rather than inherit it. New ownership, a new mandate and real investment in quality. You’d set the standards the business runs on for years to come. What you’ll own🔹 Quality Engineering strategy across FDA, ISO 13485, MDSAP and EU MDR🔹 Design controls, validation and inspection strategy, from design transfer through manufacturing🔹 CAPA and root cause. You’ll fix the recurring problems, not just manage them.🔹 Complaints, nonconformance and risk escalation🔹 The face of Quality in FDA inspections and notified body audits🔹 A seat with Operations, R&D, Regulatory, Clinical and the executive team What you’ll bring✅ 12+ years in medical device quality engineering, with 5+ leading teams✅ Orthopedic experience strongly preferred✅ Depth in GD&T, inspection strategy, process validation and statistical methods✅ Audit and inspection leadership you can point to✅ Based in North Florida, or ready to relocate What’s on offer Strong compensation, relocation support and a senior seat during a defining chapter. If you want your fingerprints on a quality organization from the start, message me for a confidential conversation.
