Hohenems, Vorarlberg, Austria
- Lead the implementation of the Quality Management System across multiple business units at Equans Switzerland, ensuring compliance with ISO 9001, ISO 14001, ISO 45001, and relevant regulatory requirements. - Manage and develop a team of quality specialists, fostering their professional growth and ensuring high performance. - Drive digitalization and automation initiatives to enhance quality monitoring, data collection, and reporting processes, increasing efficiency and accuracy. - Direct audits, monitor KPIs, and drive corrective and preventive actions in close partnership with executive management to secure compliance and improve operational performance. - Standardize processes and documentation across the organization; deliver targeted training programs to build quality, environmental, and health & safety awareness and competence. - Support internal customers during tender processes by ensuring quality requirements are met and providing expertise to strengthen proposals. - Foster a culture of continuous improvement through risk-based thinking, Lean methodologies, and cross-functional collaboration, supporting strategic and operational objectives.
Accountable for defining and executing the Digital Transformation Roadmap for Shopfloor Processes and associated value chain departments. Serve as the primary point of contact for all digitalization initiatives within the factory, working closely with Global IT and external partners. Lead structured requirements engineering for business processes and software needs, establishing the foundation for the new Digital Strategy. Provide training to factory specialists on software specification development and business process mapping. Build, train, and mentor a team of factory specialists in digital competencies to foster a more autonomous digital work culture. Drive the implementation of a Business Intelligence strategy aimed at streamlining data collection and delivering accurate information to the right stakeholders (Operator 5.0). Develop best practices that assist factory employees in transitioning from current technologies and working methods to new ones. Create internal tools leveraging Microsoft Power Platform solutions. Establish and maintain an up-to-date GMP, FDA, and GAMP5-compliant Computer System Validation process within the factory.
Nestlé Infant Formula Pilot Project – Digital Transformation and Automation of Shopfloor Quality Monitoring, Data Collection, and Reporting within a Manufacturing Execution System. Lead the project from initiation to completion. Define user requirements through close collaboration with shopfloor teams and developers. Coordinate activities between the process owner and global support/development teams. Develop and implement a Computer System Validation (CSV) procedure compliant with global FDA and GAMP5 standards. Provide training and coaching to super users and end users.
Process Owner for Document Control Management. Process Owner for Business Process Management and Improvement Initiatives. Expertise in Computer System Validation (compliant with FDA 21 CFR, PIC/S, GAMP standards). Implementation of Quality Management Systems and Processes within regulated environments (ISO 9001, IMS, GMP), including Change Management, Deviation and CAPA Management, Qualification/Validation, Document Control, Learning & Training, and Internal Audits. Preparation and coordination of external regulatory audits (FDA, CFDA). Leadership of Lean Six Sigma (Green Belt) projects. Management of process improvement initiatives such as SMED, Lean Office, quality enhancement, and cost reduction. Implementation, training, and coaching in Lean Operational Excellence methodologies, including Kaizen.
- Lean Management - Document Management