Description
Critères de l'offre
* Métiers :
* Expert air management systems
* Secteur :
* Security & Police
* Compétences :
* English
* Lieux :
* Le Vaud
* Conditions :
* Permanent contract
* Full Time
Critères de l'offre
* Métiers :
* Expert air management systems
* Secteur :
* Security & Police
* Compétences :
* English
* Lieux :
* Le Vaud
* Conditions :
* Permanent contract
* Full Time
## L'entreprise : Michael Page ##
Our client is an international company specialized in medical devices.
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## Description du poste ##
* Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
* Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.
* Analyze existing processes and ensure integration and consistency across shared, linked, and cross-functionally dependent processes.
* Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
* Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
* Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
* Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
* Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
## Description du profil ##
* Degree in Engineering, Scientific.
* 7+ years of quality-related system experience in a medical device company developing medical devices.
* Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to detail.
* Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
* Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills.
* Advanced problem-solving, organizational, analytical and critical thinking skills.
* Certified lead auditor.
* Electronic QMS experience is preferred.
* Excellent command of English language.