04 ago
|
Medicina
|
Italia
Employer
Steelco S.p.A – HQ
Location
Via Balegante 27
Riese Pio X (TV)
Italy
Department
Quality Assurance
Type of work
Tempo pieno (8.00 - 17.00)
Steelco and Belimed have joined forces to lead the way in advanced cleaning and sterile workflow solutions. This partnership is powered by our united strengths: a dynamic product range, relentless innovation, utmost reliability, and an unmatched commitment to customer satisfaction. As SteelcoBelimed, we "Innovate with confidence", as we set new industry standards to meet our customer's needs offering high-quality products and comprehensive services for Infection Control and Life Science.
Your Role
The Quality Assurance Specialist will be part of the Quality Assurance team in Riese and will be responsible for implementing and maintaining the Company's Quality Management System (QMS) in compliance with applicable industry standards.
Tasks & Responsibilities
Supports the organization in maintaining, improving and implementation of the Quality Management System.
Supports the organization in controlling the cases in the CAPA Management System regarding
Documentation quality
Time deadlines
Efficacy of Corrective and Preventive Actions
Supports the operation of the CAPA Management System and understands the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations and reportable incidents.
Performs trainings of users in CAPA processes.
Acts as interface between users of the CAPA Management Tool (super user), determines further developments of the CAPA Management Tool.
Supports process owners in updating and improving the processes of the Quality Management System.
Prepares and executes internal audits.
Takes part during audits/inspections of Notified bodies or authorities.
Supports the Business Units and plants in quality and regulatory questions.
Your Profile
Directives, regulations and standards for medical devices quality systems: MDR 2017/745, EN ISO 13485, EN ISO 9001, EN
📌 Quality Assurance Specialist (Italia)
🏢 Medicina
📍 Italia