Basel, Basel, Switzerland
Global Quality Leader who bridges Quality Management and Supply Chain, with expertise in Global Project & Process Management, Lean, regulatory compliance, and standardization across regions. Numerous project management mandates. Successfully completed various high-level projects. Driven various improvement and change initiatives to increase process performance based on key metrics. Experienced in supplier management and qualification. In-depth knowledge of establishing, managing and further developing quality management systems. Experienced lead auditor with many years of experience in internal and external auditing according to various standards. Experienced in analysing multiple norms, standards and regulations, and in their application and implementation within the organisation. Process Ownership including internal and external auditing, document management, deviation-, and process management. Always maintaining a customer-oriented attitude, focusing on requirements analysis, the implementation of improvements and the optimisation of business processes along the value chain.
• Process management & process improvement • Establishing consistent process documentation and tools • Analysis of customer requirements • Project lead for improvement project supplier management
• Implementation and integration of quality requirements • Creating and delivering new approaches and methods for business excellence and quality management • Participation in projects to improve process & performance management • Enhancing the company abilities to carry out risk analysis, to define CAPA and achieve sustainable implementation of CAPA • Participation in "round tables" and working groups to improve the implementation of quality standards & methods • Performing internal & external audits • Maintaining and further developing the document management system • Creation of process descriptions, manuals, templates or training documents considering the applicable standards
Form 4 approved Quality Manager by FOCA (Part 21 & Part 145) • Project lead to achieve company approvals (ADOA/PO/MO) • Ensuring the overall compliance to regulatory & customer requirements • Focal point of authorities and customers regarding all quality and compliance related matters • Performing internal and external audits according to DIN EN ISO 19011 • Defining, implementing & monitoring of quality improvement measures • Continuous improvement of quality procedures and quality management handbook • Defining & controlling KPIs to measure the effectivity of processes • Supervising internal error management system and occurrence reporting • Training of staff on quality management handbook and processes
• Responsible for maintaining the quality management handbook in line with business procedure under consideration of all applicable requirements • Definition, documentation and continuous improvement of business processes, process instructions & working instructions • Focal point for external auditors (authority, accredited bodies & customers) • Performing internal and external audits according to DIN EN ISO 19011 • Internal training provider • Defining and supporting the implementation of KPI • Administration & publication of all intranet content