My client is a market leader in the medical device industry. They are currently looking for a motivated validation project manager (f/m/d) for their site close to Reutlingen in Baden-Württemberg.
This is a permanent position!
The task: Creation of complete project plans, project charters, cost analyses, support business cases etc. and the documentation of the resulting project requirements Creation and definition of project milestones Planning, control, implementation and tracking of validation activities Monitoring of internal and external service providers Ensuring the achievement of project goals Participation in test planning, process validation and verification Participation in the certification of systems, subsystems Support in the planning and creation of strategically oriented plans and presentations Ensuring compliance with policies, procedures and work instructions
Your profile:Bachelor of Science/Bachelor of Engineering (medical technology or mechanical engineering) or comparable training, e.g. technician specializing in mechanical engineering, plastics technology with many years of experience in the field of medical technology or pharmaceuticals, preferably in the field of validation. Experience in project work and project management Knowledge of series production of medical devices (process technology, equipment/systems) Basic knowledge of CE/FDA approval regulations as well as FMEA knowledge and experience Experience in quality management for medical devices ISO 13485 and validation according to GHTF (Quality Management Systems - Process Validation Guidance) Knowledge of risk management for medical devices ISO 14971 and GMP for medical devices Good knowledge of statistics and goal-oriented, systematic way of working Strong analytical and conceptual thinking skills, innovative ability, assertiveness, as well as good communication skills and team spirit willingness to travel Very good knowledge of spoken and written English
What they offer:
High-quality products in the life-saving environment Remuneration according to the metal tariff, 30 vacation days per year and other attractive conditions Flexible, family-friendly working hours and mobile working JobRad and corporate benefits (employee discounts) Career opportunities in a well-known company Individual training and further training opportunities Modern workplace equipment