(Senior) Process Verification & Validation Engineer (m/w/d)
Senior) Process Verification & Validation Engineer (m / w / d)
CORTRONIK GmbH is part of the BIOTRONIK Group. BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention.
AS a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based in the latest technology and research.
Our success is based on the competence and results-oriented cooperation of our employees.
Your responsibilities
- Planning, execution / coordination and documentation of process V&V activities within development projects as sub-project manager
- Planning, coordination and monitoring of mechanical and analytical test procedures for validations as well as raw data evaluation and preparation of documentation
- Continuous improvement of processes and workflows before project handover to production
- Supporting production during transfer
- Ensuring compliance with quality requirements and normative specifications in the area of process V&V in the development phase
- Supporting and further development of business processes
- Supporting technical departments within questions from authorities and during audits
Your profile
Completed studies or comparable training with professional experience
Min. 3 years of relevant experience
Knowledge of international regulatory requirements in the area of process verification & validation as well as test method validations (, MDR, ISO 13485, 21 CFR 820, cGxP)
Confident application of verification / validation methodology / tools
Experience in defining, organizing and leading department relevant work packages
Very good written and spoken German and English skills
Product knowledge in the field of medical devices, vascular intervention and combination products is an advantage
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