Software Validation Engineer (m/f)

Baden-Württemberg  ‐ Vor Ort
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Beschreibung


We are looking for a
Software Validation Engineer (m/f)

Reference: -en
Start: asap
Duration: 6 MM+
Place: in Baden-Württemberg
Branch: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.

Your tasks:
  • Support software validation protocols and software validation performance qualification summary reports
  • Generation and revision of validation protocols, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports
  • Testing and evaluation of software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ)
  • Evaluation of validation/requalification
  • Maintain and assist in establishing standardized methods
  • Procedures for software, process, and test method validations and ensures standardized methods are implemented and followed


Your qualifications
  • Bachelor’s or Master's degree in Engineering
  • Knowledge of ISPE GAMP, FDA 21 CFR Part 11, EU Annex 11, and ISO 13485
  • Direct experience in performing software validation(s)
  • Experience in the definition and support of appropriate AQLs and sampling plans and ensuring that they are established with the appropriate documented rationale
  • Assessing and documenting the needs for improvement
  • Profound experience within the Medical Device industry
  • Good understanding in technical oral/written English and German



Skills:
- Software tester


Keywords: Softwaretester
Start
ab sofort
Dauer
6 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
09.08.2016
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1182407
Vertragsart
Freiberuflich
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