For our client, one of the worldwide leading manufacturers of measuring instruments and test
assays for clinical diagnostic and life science, we are currently looking for this permanent position near Frankfurt:

Senior Quality Assurance Engineer CAPA (m/w)

Vertragsart: Festanstellung

Auftragsnummer: A472-757

Startdatum: 01.08.2018

Einsatzort: Hessen

Job-Beschreibung:


Ihre Aufgaben:

  • Responsible for internal CAPA System in coordinating and managing the CAPA process
  • Reporting CAPA metrics internally and globally within Beckman Coulter
  • Support Operations in creation of CAPA documents and CAPA supporting documents
  • Support in Non-Conformity process and Customer Complaint handling (internal)
  • Train staff in operations and non-operations for CAPA process and related process
  • Creating and Analyzing production and quality reports using appropriate QM methods and procedures
  • Performing risk analysis / FMEA prior manufacturing

Ihre Qualifikationen:

  • University degree in an engineering discipline, Mechanical, Chemistry or similar course of study
  • At least 5 years’ experience in medical device or related industry in QA
  • High level of knowledge in Quality Assurance; Corrective and Preventive Actions (CAPA), Problem
  • Solving Process, Non-Conformity, Statistical Analysis
  • Experience in Complaint handling for internal processing and monitoring
  • GMP experience
  • High level knowledge of ISO 13485 and 21 CFR 820.
  • Fluent in German and English
  • Strong analytical and communication skills and understanding of complex relationships
  • Self-dependent working and good in supporting and motivating people to work on CAPA
  • Strong in making your points and in moving things forward