As the Quality Manager, you will lead the quality team in the Healthcare cluster, which includes four Quality Coordinators, four Quality Administrators, and a Training Coordinator. You’ll be responsible for the daily operations of the quality department and for establishing strategic guidelines within the medical device product group. Your key responsibilities will include:
- Quality Management System development and optimization: Leading the implementation, documentation, and continuous improvement of the Quality Management System (QMS), ensuring compliance with ISO 9001 and ISO 13485 certifications.
- Strategic support: Advising and collaborating with marketing, sales, account management, and the European QA team to promote quality initiatives. You’ll serve as a project manager for quality-related projects and drive improvement initiatives within Arvato.
- Quality control and risk management: Acting as a bridge between departments for managing complaints, deviations, and CAPA, while implementing strategies to prevent product counterfeiting.
- Audit management: Taking responsibility for the planning, execution, and follow-up of internal audits and supplier audits, maintaining an annual internal audit plan to ensure ongoing quality assurance and compliance.
- Product and recall coordination: Making decisions regarding product management, including recalls, blocks, and releases, and ensuring efficient handling of returns within the system.
In this role, you’ll also join the Healthcare cluster
management team (MT), collaborating closely with operations managers, the HR manager, transport manager, account managers, and the project manager.