Alexandra Muth

Support and maintain the established EMEAP QS for Commercial Affiliates with associated programs and strategies, including improving processes. Support Affiliate organizations and/or Supplier QA during daily business, new projects, audits, improvements and perform trainings.

Quality Control and Assurance for Third Party Manufacturers (TPM/OEM). Responsible for TPM quality matters: implementation of design changes; validation support; development in quality, inspection readiness and technical matters; Problem solving skills to effectively address product nonconformances. Working in global, cross functional team; Supplier Audits; Development/implementation of global process improvements.

Development and implementation of Supplier Control Process in a global project team. Selection, evaluation, approval and management of suppliers.

Realization of Supplier, TPM, Internal, External and Clinical Audits. Generalist for external audits (e.g. ISO-Certification, Regulatory Agencies, Customers). Qualification and development of TPMs. Development and implementation of the Supplier Control Program. Subject matter expert for: Quality Management Systems, Supplier Control, ISO 13485, and GMP.

Auditing, registration and accreditation of testing laboratories. Organization and realization of proficiency trials for accredited laboratories. Development of new analytical test methods (internal and DIN). Implementation of new quality concepts and procedural requirements for auditing and accreditation of laboratories. Training of laboratory quality professionals.