Highlights
Work Type: Onsite Job Description: Duties: Serve as the Global Labeling and Pacakging team member for Labeling and packaging development intiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement) and UDI tasks. Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable for labeling and packaging.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $48.58 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.
Job Title: Labeling Assoc Specialist
Location: Warsaw, IN 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Warsaw, IN 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Duties:
- Serve as the Global Labeling and Pacakging team member for Labeling and packaging development intiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement) and UDI tasks.
- Work with Regulatory, Development, Brand, Manufacturing and Other departments to develop/create labeling and packaging that complies with, EU, and UDI labeling and packaging regulations and requirements, as required.
- Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
- Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable for labeling and packaging.
- Complete Destination labeling, eLabeling for all labeling documents such as but not limited to IFU, Surgical Technique, Creating Material specification and formats for printed IFU
- Demonstrates medical packaging design and development execution within a multi-disciplinary project team desired with minor guidance.
- Assists/Conducts and owns testing to support project activities with minor guidance.
- Leads design control process related documentation to support projects with guidance.
- Serve as point of contact for Global Labeling and Packaging Developmet team for M&A sites
- If needed, travel to other sites to perform onsite activities like requirement gathering, process understanding or implementation.
Skills:
- Broad knowledge and understanding of Product Labeling and Packaging regulations.
- Demonstration of strong problem solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
- Strong ability to build and strengthen relationships with other areas of the organization (i.e. Marketing, Packaging, Development, IT) and other Business Sites.
- Good understanding of medical packaging design and development execution
- Good understanding of how labeling systems communicate with other business systems
- Exceptional attention to detail, organization, and multi-tasking skills.
- Understand the overall business environment, the orthopedic industry, and the marketplace
Education:
- Bachelor's degree in Science or Technical field with 0+ years' experience in a labeling or relevant capacity.
- Associate degree in Science or Technical field with 4+ years' experience in a labeling or relevant capacity.
- High School diploma or equivalent required with 6+ years of experience in a labeling or relevant capacity.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.