Job Description

Mission

Ensures the management and improvement of the Quality System in compliance with the legislation relating to Quality Certification, according to the objectives defined by the company. Coordinates internal audit for all Group legal entities and plants and supports them during external audit process.

Main Responsibilities

Quality Manual Management

• Releases and updates Group Quality guidelines and procedures;
• Support the plants to ensure the effective implementation of Group Quality guidelines and procedures.
• Ensures the development of the Group Quality System with the definition and updating of documents that regulate all company processes;
• Defines procedures, processes and product standards and ensures their correct application by training the staff on the quality tools that the company has decided to adopt;
• Defines quality standards in line with ISO 9001:2015 for the group and ensures the implementation of quality standards in all group locations.
• Provides support to all legal entities and plants, for the development of the local quality system and for the correct implementation of ISO 9001: 2015.
• Ensures the maintenance of manuals, procedures and operating instructions for ISO 9001:2015 certifications

Audit Management

• Responsible for the management of ISO 9001: 2015 certification. Communicates the auditors, the plan, the conduct of audits and the communication plan at the Group's sites
• Collaborates, annually, with the drafting of the context analysis and supports the Group Functions in mapping processes, updating the analysis of associated risks, and defining mitigation tools;
• Develops and contributes to the implementation of the annual Group Quality audit plan, supporting the identification and execution of required corrective actions;
• Provides support during the third part audits and keeps the relationship with third-party Certification Body to assure the Group Certification.

Quality system monitoring

• Provides and analyzes process KPI monitoring reports to improve business performance using Tableau and Business Object software
• Monitors business processes to verify the application of protocols and compliance with predefined procedures;
• Plans, and conducts internal audits verifying compliance with ISO 9001 standards at the various company functions in Italy and abroad
• Collaborates with involved functions to define processes and tools to improve and develop the system to manage and update product and process quality data, providing periodic information summaries to the functions.

Competencies

Audit Management

ISO Regulations

ISO Regulations (business continuity)

ISO Regulations (continuous improvement)

ISO Regulations (Medical devices)

Problem solving methodologies

Process Analysis

Reporting & Data Analysis