Description
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