Quality Director – Manufacturing & Design Assurance

About the role

Permobil is seeking a senior Quality Director to lead the Quality Management System for its Progeo (Italy) and Supportec (Netherlands) sites and to oversee product development and design assurance. Based in Treviso, the role combines regulatory compliance, product quality, and continuous improvement across the full product lifecycle.

Key responsibilities

• Lead and maintain a compliant QMS aligned with ISO 13485, FDA 21 CFR 820, EU MDR and global standards; act as Management Representative and EU PRRC.
• Oversee core QMS processes including CAPA, non‑conformance handling, audits, change control, complaints, validation and risk management.
• Manage design transfer and post‑market design changes, ensuring efficient and compliant implementation into manufacturing.
• Partner with R&D and Operations to guarantee manufacturability, risk mitigation, validation and traceability of design changes.
• Provide quality leadership for manufacturing investigations, product acceptance and maintenance of validated, controlled processes.
• Ensure compliant adoption and validation of automation, digital systems and AI‑enabled manufacturing technologies with strong data‑integrity practices.
• Lead audit and inspection readiness, serving as primary contact for regulatory inspections and external audits.
• Drive continuous improvement and a quality culture using Lean, Six Sigma and data‑driven decision‑making.

Required profile

• Senior quality leader with proven responsibility for regulatory compliance and QMS oversight in a medical‑device environment.
• Experience working with ISO 13485, FDA 21 CFR 820 and EU MDR requirements.
• Demonstrated ability to collaborate with product innovation and operations teams in an agile, manufacturing setting.
• Strong leadership skills to influence cross‑functional partners and promote a culture of quality.

Required skills

• ISO 13485, FDA 21 CFR 820, EU MDR compliance
• CAPA, non‑conformance, audit, change control, complaints handling
• Validation and risk management
• Lean and Six Sigma methodologies
• Automation, digital systems and AI‑enabled manufacturing technologies
• Data integrity practices