Date Posted: September 22, 2017
Employment Type: Contract To Hire
Job Id: 7915
TTP – Just opened up today
- Support the creation of product and packaging labels for compliance with notified body, FDA, and ISO requirements as well as companies own labeling policies and procedures.
- Design and maintain regulatory compliant label content as required for R&D Programs.
- Work collaboratively with Engineering, Marketing, Sales, Operations and Regulatory to create labeling for new product development and sustaining projects compliant with current standards.
- Work collaboratively with Engineering, Marketing, Sales, Operations and Regulatory to make changes to existing label formats for new product development and sustaining projects compliant with current standards.
- Assure that the label content review and approval process is comprehensive and consistently executed.
- Create label drawings utilizing SolidWorks as required.
- Create and process through to completion and DCRs to release new and revised labeling into Quality System.
- Coordinate translation and outside design services for Instructions for Use and labels as necessary to meet product distribution requirements.
- Create and maintain Standard Operating Procedures (SOP) and General Procedures (GP) relating to Labeling and other areas as needed.
- Additional duties may include:
- Supporting the Document Control process per SOP-401, Document Control, including, but not limited to:
- Review Document Change Requests (DCR’s) packages to ensure all processed documents comply with policies and procedures.
- Update Bill of Materials (BOM) as required per DCR.
- Ensure DCR training and implementation plans are complete, and notification of approved and closed DCR’s is communicated in a timely manner as required per DCR.
- Ensure released documents are copied to the S drive and that the latest released version of all documents is readily available to the user.
- Review SolidWorks Drawings and Files as required per DCR.
- Ensure quality records, including master hard copies are maintained per policies and procedures.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Knowledge of the following software programs:
- Bartender and/or other labeling software packages
- Adobe CS Suite, (InDesign, Illustrator; Acrobat)
- Microsoft Office, (Excel, Microsoft Project)
- Ability to communicate effectively with a broad spectrum of people having varying backgrounds, education, and experience
- Strong organizational and project management skills a plus
- Knowledge of Document Control and Engineering Change Systems a plus
- Working knowledge of ISO 13485 and FDA 21CFR Part 820, MDD and CMDR
- Working knowledge of electrical and mechanical design
EDUCATION AND EXPERIENCE:
- Associate’s Degree in a Graphics or Technical field or equivalent combination of education and work-related experience