Own the ISO 13485 certification roadmap from gap assessment through third-party audits
Design and build the QMS; integrate with PLM and engineering tools
Lead audit readiness and liaison with notified bodies and registrars
Establish core QMS processes: document control, CAPA, internal audits
Align PLM-based QMS workflows with the product portfolio as teams scale
Lead root cause analysis and corrective actions on quality issues

🎯 Requirements

10+ years of quality experience in medical devices with increasing leadership responsibility
Multiple ISO 13485 certifications with direct ownership
Hands-on experience building a QMS from scratch within a PLM environment
Proven track record building and developing quality teams
Working knowledge of 21 CFR Part 820, ISO 14971, and IEC 62304
Experience across hardware, software, and supply chain quality

🎁 Benefits

Flexible PTO
Equity + medical, dental, and vision benefits
Remote work option

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