Beschreibung
Senior Project ManagerMy client is currently looking for a Senior Project Manager capable of managing remediation activities to assure biocompatibility of medical devices.
OVERALL RESPONSIBILITIES
-Advisory and support of the manufacturing sites and the development department in the implementation of a global biocompatibility process.
-Coordination of activities regarding biocompatibility in consultation with the remediation manager.
-Assessment of the biocompatibility of existing products and production processes according the internal standards.
-Developing of best practices, tools and templates to assure the complete and traceable documentation of the product's biocompatibility (part of the Design History File (DHF) and Device Master Record (DMR)).
-Support of the risk management assessing the risk of products and processes regarding biocompatibility.
-Assure that the proceeding is align with international standards and guidelines
-Developing and performing trainings of the process at different sites
REQUIREMENTS
-Co-Management of the remediation activities assure the biocompatibility of medical devices.
-Assistance of Implementation of a global biocompatibility process in EMEA.
-Experiences in medical devices, pharma or chemical industries.
-Knowledge of the standard family ISO 10993 and process and cleanliness validation.
-Experiences of Good Manufacturing Practice (GMP) and design control processes.
-Proficient with MS-Office Tools (Word, Excel) as well as SAP.
-Fluency in English & German (Verbal and Written).
Special working conditions: Place of work at different manufacturing sites in Switzerland, travel to Southern Germany and Austria necessary
If you are interested in this project or need further information please send your CV directly to Beni Wehrle. You can call me on
Keywords: Labelling, document review, quality management, quality control, SOP, EMDR, ISO , 93/42/EEC, Medical Devices, German and English, Switzerland, Freelance
Campaign Ref: CH
To find out more about Real please visit www.realstaffing.com