Quality Engineer (m/f)

REFERENZNUMMER:

263143/14

IHRE AUFGABEN:

-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.

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist