Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations. Covers the full lifecycle from gap analysis through certification, plus the FDA QMSR transition (effective Feb 2026), digital/electronic QMS, and AI-enabled device considerations.

Core Capabilities

• QMS implementation — gap analysis, Quality Manual (Clause 4.2.2), the 6 mandatory documented procedures, four-tier document hierarchy, certification readiness
• Document control — numbering conventions, change control, review schedules, electronic document management (eDMS)
• Internal audit — annual audit programs, individual audit execution, auditor qualification, finding classification (Clause 8.2.4)
• Process validation — IQ/OQ/PQ protocols, revalidation triggers, special-process examples (Clause 7.5.6)
• Supplier qualification — A/B/C categorization, scored evaluation, monitoring, software/cloud provider assessment (Clause 7.4)
• Cross-framework integration — FDA QMSR, 21 CFR Part 11 / EU Annex 11, ISO 42001 (AI), remote/hybrid audits, cybersecurity-driven CAPA

When to Use

• Building an ISO 13485:2016 QMS from scratch or remediating gaps
• Preparing for or transitioning to the FDA QMSR
• Establishing document control, internal audit, validation, or supplier programs
• Modernizing to a digital/electronic QMS (Part 11 / Annex 11)
• Integrating AI-enabled device or cybersecurity requirements into the QMS