수평: Entry level

직업 종류: Full-time

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작업 내용

  • Multinational company|QA Complaint / Post Market Surveillance management
About Our Client

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.
The Successful Applicant
  • 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.
What’s On Offer

Great opportunity to join a large organization on an exciting project.

Contact: Sidonie Newton

Quote job ref: JN-022022-5256561

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마감 시간: 05-05-2024

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