Quality Specialist

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 possibilities and translating them into breakthrough strategies.
• Cultivates Innovation: Creating new and better ways for the organization to be successful.

Takes personal ownership on important issues to do what is right and achieve organizational success and supports others who do so. Challenge’s decisions where appropriate.

Employment Terms and Compensation

The position is offered under the Italian National Collective Bargaining Agreement for the Commerce sector (CCNL Commercio) , with a Gross Annual Salary (RAL) ranging from €35,000 to €45,000 , paid over 14 monthly and consisting of both a fixed and a variable component. The final compensation package will be determined based on the candidate’s professional experience, acquired skills, and demonstrated level of autonomy, ensuring alignment with the role and the company’s internal equity principles.

Benefits

• Employee Benefits
  • Career Growth Opportunities: Mentoring programs, personalized career plans, and regular performance reviews to support professional development.
  • Birthday Leave: A paid day off on your birthday to celebrate your special day.
  • Hybrid Working: Flexible work arrangements combining office-based and remote working.
  • Learning & Development: Access to training courses, workshops, e-learning platforms, and industry events.
  • Corporate Volunteering: Opportunities to contribute to social and environmental causes through company-sponsored volunteering activities.
  • Psychological Support: Confidential professional support to promote emotional well‑being and work‑life balance.