Description
We are looking for a
Quality Engineer (m/f)
Reference: -en
Start: asap
Duration: 4 MM
Place: in Baden-Württemberg
Branch: Unternehmensberatung
Your tasks:
- Product quality, control & disposition and performance standards
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints/material identification, material segregation, classification of defect types
- Review root cause investigation according to an established process
- Support in production/process controls including control plans
- Process validation, process control and risk management/IQ, OQ, PQ
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
Your qualifications
- Experience with working in FDA and European regulatory environment
- Experience with working in manufacturing/operations (GMP)
- Knowledge of product/process risk management / risk mitigation (FDA and ISO standards)/(PFMEA/DFMEA)
- Experience in using Statistics, Lean and Six Sigma Methodologies
- Understanding of the NPI (New Product Introduction) process
- Audit Experience
- Experience with CAPA
- Experience with IQ, OQ, PQ, (DQ) experiences
- Experience with CSV
Skills:
- Qualification/validation specialist
Keywords: IQ OQ PQ validation kaizen PFMEA GMP FDA ISO Six Sigma Process