Labeling Designer (Medical device)

Labeling Designer (PHIAJP00004041)

Duration: 12 months

Location: Colorado Springs, CO

From the manager: If you can find a candidate that has design and project management experience, that would be very beneficial.

You are responsible for ·
Develop and maintain Instruction For Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy.
Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats.
· Use of PLM (Windchill) for document control process to route all work for approval
· Perform prepress activities necessary to prepare labeling artwork files for accurate output.
· Prepare and route labeling packages for 1st article and approvals.
· Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices which focuses on a first-time right approach. Attention to detail with minimal errors is key.
· Reviews and updates as necessary to ensure proper revision control and storage of all labeling.
· Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments.
· Can successfully work with cross-functional teams to address NCRs and CAPAs. Investigate, analyze, and identify root cause. Evaluate underlying issue and find long-term solutions.
· Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes.
You are a part of A recently restructured organization dedicated to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact within the team, our business, and health technologies that will improve the health, well-being and care for people around world. Additionally, we believe that people are #1 and are intentional about creating a culture that reinforces that.

To succeed in this role, you should have the following skills and experience
· Bachelors degree or equivalent relevant experience required
· Proficient in Adobe Creative Suite and Microsoft Office
· Experience with Adobe Lifecycle is preferred
· Exposure to Bartender, EnLabel, Windchill and/or SAP is a plus
· Knowledge of Regulatory standards (FDA, EU MDR, Japan, Canada, ISO standards) is preferred
· Excellent written and verbal communication skills
· Ability to exercise independent judgment consistent with company policy
· Ability to organize and prioritize workflow
· Ability to interact with all levels of employees including senior management
· Ability to adapt to changing processes and learn programs/software quickly
· Strong attention to detail is critical.

Thanks, 

Amit Sehdev

APN Software Services Inc.

Direct: |Cell: | Fax: |
LinkedIn: