Quality Compliance Engineer

JR Italy; Verona; Ibrido; EUR 35.000 - 40.000; Tempo pieno

Descrizione del lavoro

Ein innovatives Unternehmen im medizinischen Bereich sucht einen Quality Compliance Engineer, um sicherzustellen, dass die Qualitätsstandards eingehalten werden. In dieser spannenden Rolle arbeiten Sie eng mit dem Qualitätssicherungsteam zusammen und tragen zur kontinuierlichen Verbesserung von Qualitätssystemen bei. Sie werden die Möglichkeit haben, Ihre analytischen Fähigkeiten zu entwickeln und in einem unterstützenden, dynamischen Umfeld zu wachsen. Mit einem hybriden Arbeitsmodell und zahlreichen Entwicklungsmöglichkeiten ist dies eine hervorragende Gelegenheit für Fachleute, die in einem freundlichen und inklusiven Team arbeiten möchten.

Servizi

Wohlfahrtsprogramme

Pensionsfonds

Gesundheitsversicherung

Cafeteria-Angebote

Soziale und Unternehmensveranstaltungen

Schulungs- und Entwicklungsmöglichkeiten

Competenze

• 1-2 Jahre Erfahrung im Management von Qualitätssystemen in multinationalen Unternehmen.
• Interne Auditorqualifikation ist von Vorteil.

Mansioni

• Unterstützung bei der Wartung und Verbesserung des ISO 13485-Qualitätssystems.
• Überwachung von CAPA-Untersuchungen und deren Qualität.

Conoscenze

Qualitätsmanagementsysteme

ISO 13485

MDSAP

FDA QSRs

Analytische Fähigkeiten

Englischkenntnisse

Formazione

Technischer Abschluss in Ingenieurwesen (vorzugsweise biomedizinisch)

Strumenti

Microsoft Office

Analytische/Reporting-Tools

Descrizione del lavoro

We offer an interesting opportunity to join our Quality & Regulatory team, based in Bussolengo (VR), as a Quality Compliance Engineer, reporting to the Senior Quality Compliance Manager, on a temporary one-year contract.

In this position, you will collaborate with the Quality Assurance team to ensure that the Orthofix Quality System complies with all relevant standards and regulatory requirements (ISO 13485, MDSAP, FDA QSRs, RDC 59/2000, etc.) and that supplied products are fit for their purpose and meet customer expectations. You will also ensure that CAPA actions opened by the organization are properly managed.

Your responsibilities include supporting the management of QMS documentation and updates, participating in internal audits to verify system compliance, addressing deviations, and supporting the development of post-market reports with compliance data.

This role involves interaction with various departments and international colleagues, including Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, Suppliers, and the Notify Body.

What will your contribution be?

1. Supporting the maintenance and continuous improvement of the ISO 13485, MDSAP, and other quality management systems.
2. Driving strategies to achieve site and division quality and compliance goals regarding CAPA investigations and metrics.
3. Supervising a team of qualified investigators across multiple functions to analyze and resolve root causes.
4. Reviewing CAPA investigations for thoroughness, completeness, and traceability.
5. Managing resolution confirmation processes and working with event owners and management to ensure CAPA quality and timeliness.
6. Developing training materials and strategies for CAPA program members to maximize performance and compliance.
7. Leading the CAPA Review Board (CRB) process and executing quality signatory authority for nonconforming products.
8. Verifying product safety and efficacy, and addressing safety-related issues for risk evaluation.
9. Monitoring metrics to identify adverse trends and their drivers.
10. Authorizing changes to the CAPA Management System.
11. Serving as the primary contact during regulatory inspections and audits.
12. Recruiting staff and resources to support the CAPA program.
13. Supporting quality system health monitoring through audits.
14. Collecting, evaluating, and analyzing quality records; reporting corrective and preventive actions to management.

What are we looking for?

• Preferred technical degree in Engineering (especially biomedical) or similar.
• 1-2 years of experience in similar roles or managing Quality Systems in structured, preferably multinational, companies in the Medical Device field.
• Internal auditor qualification is a plus.
• Excellent written and spoken English skills.
• Proficiency in Microsoft Office and analytical/reporting tools.

What soft skills will you develop?

• Critical thinking.
• Decision-making and problem-solving abilities.
• Strong organizational and analytical skills.
• Teamwork capabilities.

What will you find?

• A friendly, warm, innovative, and inclusive work environment.
• Opportunities for training and development.
• A hybrid work model (two days per week).
• Competitive salary packages.
• Social and company events.
• Wellbeing initiatives, including welfare programs.
• Canteen facilities.
• Benefits such as Pension Fund and Health Insurance.

What do we offer?

• A full-time position.
• A one-year temporary contract.
• Salary range: €35,000 - €40,000 annually.

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