QA Complaint / Post Market Surveillance Specialist
Vue: 258
Jour de mise à jour: 21-03-2024
Localisation: Fribourg Fribourg FR
Catégorie: Science La main doeuvre Santé / soins médicaux
Industrie: IT Services IT Consulting Staffing Recruiting Financial Services
Niveau: Entry level
Type d’emploi: Full-time
le contenu du travail
- Multinational company|QA Complaint / Post Market Surveillance management
Our client is a multinational company specialized in IVD.
Job Description
- You support the PMS activities and complaints handling process, and have the QA oversight of the product customer complaint management activities.
- You lead the preparation of PMS plan and report, ensure timely analysis of the data.
- You support the products support staff in managing and resolving complex complaints and initiate product quality actions (Hold, Field Action, Field Safety Notice) when needed.
- You develop and track meaningful metrics to monitor process effectiveness and communicate results and product trends to internal stakeholders.
- You provide leadership to continuously improve the Quality System in accordance with the Global QA strategy and in compliance with European (IVDR) and FDA requirements.
- You participate to authority, notified body and customer audits. You participate to the internal audit program as Internal Auditor and to external audits as Quality Expert, especially for complaints system.
- You support, when necessary, Quality Management System activities and projects as Quality referent for deviations, change control and CAPA or Project lead.
- You have a master’s degree in biology, biotechnology, or similar field.
- You show at least 5 years of experience in a similar position associated to/with complaint handling, preferably in a Diagnostic environment.
- You have a strong knowledge and understanding of regulatory agency (cGMP/ISO) requirements, as well as IVDR requirements for Post market Surveillance activities.
- You have an expertise in quality systems.
- You have a strong ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions. Experience in Lean or Six Sigma projects is an asset.
- Fluent in French and English (spoken and written), German an asset.
Great opportunity to join a large organization on an exciting project.
Contact: Sidonie Newton
Quote job ref: JN-022022-5256561
Date limite: 05-05-2024
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