EU Distribution Center Quality System Specialist

WERFEN

JOB DESCRIPTION: EU Distribution Center Quality System Manager

Title of position: EU Distribution Center Quality System Manager

Name of Department: Quality Assurance

Location: Roncello Distribution Center, Italy

This position reports to: Quality and Environmental System Manager

Position Summary

Supporting the QA and Supply Chain Departments to develop and sustain the Quality and Environmental Management System in the European Distribution Center in line with the required industry standards (including ISO and medical Devices regulations), accreditation requirements and business requirements, through existing and new procedures.

Key Accountabilities

• Evaluating the compliance of the Supply Chain processes with the requirements of the ISO 13485, ISO 9001 and ISO 14001 standards applicable to the management system of the European Distribution Center;
• Managing the documentation of the quality management system, monitoring its updating status and checking its revision;
• Monitoring the non-conformities of the management system, managing the corrective and preventive actions by following their assignment, follow-up, closure and verification of effectiveness;
• Monitoring the quality data analysis, intervening with corrective actions and process improvement proposals;
• Supervising and supporting the compliance of the Supply Chain processes at the EU Distribution Center with all the general obligations applicable to the European Importer, as required by the MD and IVD Regulations.

In particular, at import:

• • The verification that the devices being imported from extra-EU countries are CE marked and that the EU declaration of conformity is available in the appropriate SAP repository;
  • The verification that the labeling includes the identification of the legal manufacturer and its EU authorized representative and the UDI.

At storage and delivery:

• • The verification that the name, the registered place of business and the address of the importer are provided along with the products, in a document accompanying the device;
  • The verification that storage or transport conditions are based on the conditions set by the manufacturer;

In case of non-conformities, keep records of them in SAP and inform the manufacturer and the manufacturer's authorized representative.

• Collaborating with the RA Italy and RA Corporate to coordinate with the manufacturer the implementation of the corrective actions and to verify that the device is registered in the European electronic system (Eudamed);

• Supervising the quality control process related to the product labeling and finalization and ensuring the release of the product and the DHR management according to the ISO 13485 requirements;
• Supporting the EU Distribution Management in the monitoring of the environment and equipment according to the Good Distribution Practices (GDP);
• Coordinating the change management applicable to the EU Distribution Center and the related validation activities;
• Supporting the certification bodies, the notified bodies and the suppliers in external audits of the management system.

Budget managed (if applicable)

N/A

Internal Networking/Key relationships

• Internal: Quality Assurance and Regulatory Affairs - Supply Chain - General Services (or facilities?)
• External: Certification Bodies - Notified Bodies - Suppliers - Corporate Quality Assurance and Regulatory Affairs – Corporate Supply Chain - Werfen Manufacturing

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and competencies:

• Analytical and critical thinking
• Attention to detail and accuracy
• Time management and priority setting skills
• Proactive problem solving
• Planning and organization skills
• Teamwork and cooperation

Min Knowledge & Experience required for the position:

• Education: Degree in scientific disciplines
• Experience:
  • At least 5 years of experience gained in in the Medical Device/Pharma Supply Chain field, in Quality Assurance/Quality Control roles
• Additional Skills/Knowledge:
  • Knowledge of international standards, with particular reference to ISO 13485
  • Knowledge of IVD/MD Directives and Regulations
  • Knowledge of GDP
  • Knowledge of process validation
  • Strong Computer skills:  Office package / SAP …
  • English language: level C1
  • Spanish language: preferable
  • Auditing / Compliance skills to identify and manage risk compliance
  • Statistical analysis
  • Project management skills

International Mobility:

• Required: No

Travel requirements:

• Up to 25-30% of time