Daniela Rocca Email & Phone Number

Roma

Roma, Lazio, Italia

• Plan and conduct internal audits to verify the effectiveness of QMS
• Prepare/ coordinate external audits
• Perform supplier audits as required
• Support/provide training to the organization about the ADD QS
• Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and timely closure
• Coordinate Field Communications at the Region

Roma, Italia

• Ensure Quality System awareness and compliance in the affiliate/ Region/ EMEAP HQ
• Plan and conduct internal audits/ assessment to verify the effectiveness of the management system
• Perform supplier audits as required.
• Prepare/ coordinate external audits.
• Receive audit input and follow QS Document Control if applicable
• Support/provide training to the organization about the ADD Quality System.

Roma, Italia

Coordinate/ ensure Quality Assurance and Regulatory Assurance services across several European countries.Coordinate/ ensure EU and region supplier evaluation and monitoring with the team Review EU and Regional laws & regulations (including Environmental, Health & Safety) with the Regulatory Affairs team. Evaluate/ describe consequences for the company and.

Roma, Italia

Preparation of all Quality Management System (QMS) documentation ensuring its follow-up and implementation; Update, distribution and archiving of all documentation of the QMS (Quality Manual, General Procedures, Standard operating Procedures, Technical files, Risk analysis, Labelling, Performance Evaluation, Stability Studies); Management of EN ISO 13485.

Pomezia

Management Customer Care and post-sale support;Collaboration with sales force, suppliers and distributors;Collaboration with technical service for problem solving;Training to customers and distirbutors on IVD kits and instruments;Management of technical documentation and promoting material.