Stryker a medical devices company is looking to hire a Document Controller, this is for the new manufacturing plant being built in Skawina. This is a new manufacturing plant for Stryker in Poland. The person on this role will manage the documentation for the whole plant.

Responsibilities:

• Responsibility for all activities around document forwarding, distribution and release to ensure that the latest valid versions are available
• Timely archiving and storage of all documents from Stryker
• Quickly retrieve of documents and information for investigations and/or reports
• Subject matter expert for managing, updating and revising documents and further responsibility for improving procedures and systems using current best practices
• Subject matter expert (superuser) for the product lifecycle management (PLM)-system
• Provide coaching, trainings, courses, support, and services to functions that use and work with the PLM system, as well as for the execution of documentation and change processes
• Promote and support improvement initiatives within the Quality Systems team and participate in multi-functional teams to achieve common objectives
• Effective collaboration and communication with professional disciplines to ensure efficient, constructive interdepartmental interactions with regard to documents
• Conduct trainings for cross-functional groups on product lifecycle management and regulatory requirements for document control
• Regular/demand-oriented participation in the product development team
• Support compliance with Good Manufacturing Practice/Quality System requirements, ISO 13485 and CE Marking
• Contribute to and manage quality KPI’s for trend/management reviews
• Assist in investigating, correcting and resolving issues, follow up’s and process improvements
• Maintaining an organized, clean, safe and health-conscious work environment
• Support regulatory audit activities of the company as needed

Qualifications:

• Experience working in a regulated environment
• A University degree
• Fluent in Polish and English
• Knowledge of quality management system good to have