Designs, implements and optimizes production processes, improving efficiency, reducing costs and ensuring compliance with current regulations for the production of medical devices.
· Provides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc.
· Through the use of data, identifies and implements process parameters setup and changes that will improve quality and productivity
· Supports new product launches and executes process changes related to: methods, parameters and material changes
· Originates and investigates quality events using RCA
· Writes and executes regulatory documentation including Operational Qualification (OQ) and Performance Qualification (PQ)
· Leads the installation and validation of equipment
· Builds internal/external system to support replication of best practices and lessons learned
· Tracks equipment downtime, identify bottleneck, and report downtime appropriately
· Implements and maintains std operations along all the production lines: layout plan, process improvement plan and execution, equipment capacity estimate
· Supervises the implementation of Lean Management techniques in all the areas of the organization
· Analyzes and identifies potential areas of processes improvement
· Manages documentation and lean outcomes control, supervises improvement actions
STERILIZATION PROCESS EO, EBEAM, STEAM
· Writes and reviews procedures concerning sterilization process and its validation tests
· Schedules validation and re-validation programs issuing the relative Validation Plan and Reports
· Evaluates and approves validation protocols issued by external sterilization suppliers
· Analyzes process or validation deviations and identifies corrective actions in agreement with QA
· Checks the application of validated sterilization cycles in case of new product / change
· Evaluates and analyzes any possible equipment change implemented by supplier by means of relative documentation checking
· Receives/Performs the periodical inspection of sterilization norms and regulations and plans the purchasing of new revisions by issuing the gap analysis between versions
· Provides training concerning sterilization process
· Analyzes and identifies potential areas of improvement for sterilization process / documentation by attending the “best practices sharing plant to plant” meetings.
Technical knowledge, special trainings:
Important personal qualities:
Permanent contract in a multinational context
At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.
All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.