Senior Quality Engineer-Document Control

Work Flexibility: Hybrid

• Assist in the management of Corporate GMP document and data additions and modifications
  • Assist authors with the creation and revision of Corporate quality documents
  • Ensure proper template usage and formatting
  • Manage document review, comment, and approval processes
  • Ensure proper form completion
  • Management and troubleshooting of documentation workflows
  • Management of documentation of divisional and other site implementations, delays, and exclusions
  • Provide training support as needed and/or requested
  • Act as CAI, CAII, and CAIII in onePLM
  • Manage Corporate Quality records
• Write, format and edit documents, including Standard Operating Procedures, Specifications, Forms, and Policies that support GMP operations to ensure compliance with cGMP and FDA guidelines and with additional quality standards addressed in Stryker’s Quality Manual
• Develop and support implementation of improved business processes including creating and revising procedures and workflows
• Ensure adherence to the Standard Operating Procedures that govern the Stryker Corporate document management system
• Provide input and support for managing corporate documentation schedules, documentation issues, etc.

Perform other related duties and special projects as required or requested.