Quality Assurance Specialist

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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 controling 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
Skills & Competencies
- Directives, 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gf622