- This individual will be the main Packaging and Labeling core team member for the EU-MDR program.
- This program will require design changes to packaging components and labeling on a portfolio of products (30+). Key activities will include execution of the Packaging Testing, authoring and/or editing Packaging test protocols and reports and managing the Label Design process.
- This person will also coordinate and track the execution of all associated design deliverables for a change from other cross-functional representatives – Design Quality, Regulatory Affairs, Supplier Quality and Operations.
- Ability to coordinate and execute a *high* workload in a regular cadence.
- Project Management / Project Coordination / Thrive in Team environment
- Proficient in Technical writing (Medical Device Quality System deliverables).
- A high level of detail orientation
- Proofing experience (Graphics and Text)
- Experience with Task or Job Tracking
- Service orientation 8) Familiarity with Packaging Engineering Testing (11607 / ISTA).
- Proficiency with MS Word and MS Excel
- Familiarity with MS Project / MS Visio / Adobe InDesign or Illustrator
- Knowledge of PLM/PDM systems and Change requests
- 3-5yrs with Packaging Engineering
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