Quality Specialist
Pubblicato il 06-10-2026 - Olympus 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 Mi