Project Validation Specialist

The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.
• Data Gathering – Participate in the discovery and compilation of required documentation to be updated as part of the Labeling / artworks changes implementation.
• Labeling / artworks changes implementation – Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement Labeling / artworks changes. Perform tasks identified as part of the implementation plan including, but not limited to generation and execution of change control, technical reports / memos, First Article Insp
Requisitos:
• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
• Experience with managing documents within electronic PLM system.
• Experience with working with cross functional team.
• Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.