Director of Quality Compliance & Validation Strategy
Core
Own the Quality Management System (QMS) and lead compliance initiatives for a hardware/software company serving regulated industries, primarily medical devices.
Role type
Director of Quality Compliance & Validation Strategy
Builds
Validated solutions for industrial CT scanning and metrology systems used in medical device, automotive, aerospace, and defense sectors.
Domain
Medical devices / Industrial manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) design and implementation, ISO 9001/13485/17025 compliance, 21 CFR Part 820/11 knowledge, Computer Systems Validation (CSV), IQ/OQ/PQ execution, audit management, strategic advisory, cross-functional leadership, continuous improvement.
Preferred skills
Lead Auditor certification (ISO 9001/13485/17025), ASQ CQA/CQE, FDA 510(k)/PMA support experience, industrial CT/metrology background, calibration lab setup, statistical process control, MSA/CAPA/PPAP.
Technologies
ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, 21 CFR Part 11, IATF 16949, AS9100, EU MDR, FDA 510(k), PMA, industrial CT, CMM, GD&T.
Responsibilities
Design and maintain a unified QMS covering hardware, software, and cloud services; lead compliance programs for ISO standards; work with customers to validate systems; manage internal and external audits; advise engineering and product teams on regulatory requirements; drive continuous improvement across the organization.
Seniority
Director, strategic leadership & cross-functional enablement
