About the role

Project Support: New biocompatibility strategy – strategy and implementation of a new Document System and Structure to satisfy global biocompatibility requirements.

What you’ll be doing

• Participate in a specific Project of Zimvie's Quality & Microbiology Area associated with the standards and biocompatibility requirements of medical devices according to ISO 10993.
• Review and analyze the historical documentation of the Quality System to obtain the inputs that allow the design and optimization of the company's new strategy in terms of compliance with biocompatibility requirements.
• The documents to review would be, but not limited to, risk analysis reports, manufacturing procedures, production process flows, validations of production processes, material specifications, packaging, contact materials involved in production, safety data sheets.
• Write procedures and work instructions related to the project.
• ...