Label Technition I - CR

Job Description

Job Title

Job Description

In this role, you have the opportunity to

Utilize Graphic, Labeling and Barcode software to develop labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP’s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. Knowledge of EU MDR 2017 and 13485:2016 Regulations is preferred.

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 Live Cycle and En Label 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, bar code 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.
• 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 leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.

To succeed in this role, you should have the following skills and experience

• Bachelor's Degree or equivalent
• Advanced English Level
• Proficient in Adobe Creative Suite
• Proficient in Microsoft Office
• Literate in Adobe Lifecycle preferred
• Literate in Bartender, EnLabel, Windchill and SAP preferred
• Knowledge of Regulatory standards (FDA, EU MDR, Japan, Canada, ISO standards)
• NCR and CAPA evaluation, root-cause analysis and implementation
• 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 navigate through PC desk top, computer drives, directories, folders, applications, etc.
• Ability to adapt to changing processes and learn programs quickly
• Strong attention to details is critical
• Work is performed under minimal supervision; work is reviewed for accuracy
• Ability to anticipate needs and take ownership of tasks with minimal errors

In return, we offer you

In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.

**Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.**

Contact

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