Description
Summary Description:
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 Inspections, and manufacturing documentation update through site change orders system (Agile).
The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
Education and/or experience:
• 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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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