Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b6rgb

ppbEmployer /bbr/Steelco S.p.A – HQ /p pbLocation /bbr/Via Balegante 27br/Riese Pio X (TV)br/Italy /p pbDepartment /bbr/Quality Assurance /p pbType of work /bbr/Tempo pieno (8.00 - 17.00) /p pSteelco 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. /p h3Your Role /h3 pThe 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. /p h3Tasks Responsibilities /h3 ul liSupports the organization in maintaining, improving and implementation of the Quality Management System. /li liSupports the organization in controlling the cases in the CAPA Management System regarding ul liDocumentation quality /li liTime deadlines /li liEfficacy of Corrective and Preventive Actions /li /ul /li liSupports 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. /li liPerforms trainings of users in CAPA processes. /li liActs as interface between users of the CAPA Management Tool (super user),



determines further developments of the CAPA Management Tool. /li liSupports process owners in updating and improving the processes of the Quality Management System. /li liPrepares and executes internal audits. /li liTakes part during audits/inspections of Notified bodies or authorities. /li liSupports the Business Units and plants in quality and regulatory questions. /li /ul h3Your Profile /h3 ul liDirectives, regulations and standards for medical devices quality systems: MDR 2017/745, EN ISO 13485, EN ISO 9001, EN ISO 14971, 21CFR Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821 Medical Device Tracking etc. /li liExcellent English language skills (Advanced C1). /li liStrong team work skills. /li liHands on mentality. /li liFlexibility, reliability, mediation skills, and a strong sense of responsibility. /li /ul h3Skills Competencies /h3 ul liDirectives, regulations and standards for medical devices quality systems: MDR 2017/745, EN ISO 13485, EN ISO 9001, EN ISO 14971,



21CFR Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821 Medical Device Tracking etc. /li liExcellent English language skills (Advanced C1). /li liStrong team work skills. /li liHands on mentality. /li liFlexibility, reliability, mediation skills, and a strong sense of responsibility. /li /ul h3Required Experience /h3 ul liPrevious experience in a similar role is prerequisite, particularly in quality management systems for medical devices and/or other regulated industries. /li li5 years of experience in an international acting company. /li /ul h3Required Education /h3 ul liBachelor’s degree in or another similar scientific discipline. /li /ul h3Our Offer /h3 ul liWork in an international, fast-growing industry that makes a real impact on healthcare and pharmaceutical industry. /li liBe part of an innovative and open-minded team. /li liJoin a company with a strong reputation and long-standing expertise in cleaning and disinfection solutions. /li liWe offer a people-focused work environment, with dedicated benefits and welfare initiatives. /li /ul pReady to make an impact? Apply now and join our team! /p pThe personal data contained in your resume will be processed by Steelco S.p.A., with registered office in Riese Pio X – TV, Via Balegante 27 (“Company”), for the selection process relating to this position or other similar positions. Detailed information, including information on the rights recognized by the legislation on the protection of personal data, can be found in the information notice available on the Company's website on the “Careers” page ( /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b6rgb