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.
To succeed in this role, you should have the following skills and experience
· Bachelor's 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
location: Colorado Springs, Colorado
job type: Contract
salary: $45 - 52 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
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.
qualifications:
- Experience level: Experienced
- Minimum 4 years of experience
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
