Entreprise : Our client is a medical device company focusing on the development of treatment solutions for liver diseases and heart failures.
Description du poste : * Management of all tasks with respect to the verification and validation activities (e.g. validation of software, processes, products, equipment etc.
as well as all associated revalidation activities* Responsible to generate, review, edit and approve qualification and validation / revalidation protocols, process specifications, FMEAs, test plans and summary reports as well as other associated documents to allow conformance to regulations and standards* Responsible to generate, review, edit and approve, SOPs, CAPAs, and other applicable documentation as part of the identified tasks during the verification and validation activities* Responsible to analyze testing results using statistical techniques and determining acceptability* Responsible to investigate and troubleshoot problems identified during and associated to verification and validation activities and to determine solutions or recommendations for changes and / or improvements* Responsible for the validation of software used within the quality management system (e.
g. software controlled test equipment used during in-process inspection)* Support the change control proves of SOPs and other applicable documents* Support the preparation and update of the respective KPIs and management reports* Lead cross-functional teams to plan and facilitate Qualification / Validation activities within the organization* Responsible to cover the QA area while vacationDescription du profil : * Technical Bachelor s Degree in a related field, Master's Degree an advantage* At least four years of experience within the field of medical device verification and validation* Experience in Quality Assurance activities / techniques* Strong technical expertise when reviewing and approving validation protocols, process specifications, FMEAs, test plans and summary reports and other verification and validation related documents* Experience in FDA / GMP / QSR / ISO13485 and within statistical techniques* Proven leadership qualities, including making decisions to meet the goals set and leading effective meetings* Ability to develop a "hands-on" approach, requiring personal initiative, reliability and responsibility while operating at a high level of performance and efficiency maintaining confidentiality and meeting deadlines* Strong written and verbal communication skills, including report writing* Fluency in English is required, additional languages (e.
g. German) would be beneficial