Quality Specialist
Pubblicato il 17-08-2026 - Altro in Segrate
Responsibilities Quality Governance & Compliance: Implement, maintain, and monitor site QMS; ensure compliance with ISO 9001, ISO 13485, and other national and international regulations.
Audit Readiness: Lead and coordinate internal and external audits; ensure corrective actions are implemented.
Training & Competence: Deliver or coordinate mandatory quality training; maintain competency records.
KPI & Reporting: Track and report site quality metrics, including complaints, CAPA, nonconformances, inspection findings, FCAs, etc.
Culture & Leadership: Promote patient safety and quality culture; ensure staff adherence to policies.
Cross‐functional Support: Collaborate with business functions (Operations, Regulatory, Commercial) to ensure smooth operational execution and risk mitigation.
Business Areas Field Service Oversight: Ensure field service procedures follow QMS and risk management.
Distribution & Storage: Monitor storage, shipment, cold‐chain (if applicable), and product integrity.
Customer Feedback Integration: Ensure complaints, returns,
and feedback from field service/sales are captured in QMS.
Regulatory Compliance: Oversee labeling, documentation, and local regulatory requirements for shipped devices.
KPI Monitoring (Commercial): Track delivery quality, field service incident rate, and customer satisfaction metrics.
Qualifications Instills Trust: Gaining the confidence and trust of others through honesty, integrity, and authenticity.
Situational Adaptability: Adapt approach and demeanor in real time to match the shifting demands of different situations.
Drives Results: Consistently achieving results, even under tough circumstances.
Decision Quality: Making good and timely decisions that keep the organization moving forward.
Balances Stakeholders: Anticipating and balancing the needs of multiple stakeholders.
Collaborates: Building partnerships and working collaboratively with others to meet shared objectives.
Strategic Mindset: Seeing ahead to future possibil