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Labeling Specialist - Quality

In Illinois / United States

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Labeling Specialist - Quality   

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JOB TITLE:

Labeling Specialist - Quality

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Abbott Park Illinois / United States

JOB DESCRIPTION:

Labeling Specialist
Pay Rate: $41.16/HR


The UDI Labeling Quality Control Specialist will support the review and implementation of quality system elements and product labels with respect to compliance with Global UDI requirements. This role will operate as a key team member of a focused team implementing Global UDI infrastructure across key Rapid Diagnostics (ARDx) sites (virtual visits). At each site, this team will work
with various functional teams (R&D, marketing, regulatory, quality, engineering, manufacturing) on quality system elements and labelling requirements and analysis related to global UDI Implementation for medical devices

Essential Duties and Responsibilities (Key Activities)
? Carries out duties in compliance with established business policies and procedures.
? Responsible for exhibiting professional behavior with both internal/external business associates
that reflects positively on the company and is consistent with the company’s policies and
practices.
? Responsibility to understand and maintain awareness of the quality consequences which may
occur from the improper performance of their specific job.
? Assist Project Manager as a Tiger Team Member in daily activities related to the UDI
implementation and maintenance activities, as assigned.
? Quality Management System Alignment: Review and redline legacy site quality management
system documentation to align with Divisional Global UDI SOP requirements.
? Label Verification: Ensure data accuracy between labels and master UDI data and global UDI
labelling requirements consistently implemented.
? Works with other functions to identify and resolve labeling inconsistencies with UDI
requirements in order to meet project objectives. Redline and update labelling, as required.
? Manage UDI label change controls to plan, prepare and submit complete and accurate change
requests within a PLM system/ Abbott’s Agile Quality Management System. While ensuring
correct implementation strategy is applied
? Support Project Manager during project execution with various data related needs.
? Collaborate, communicate, and provide status to key stakeholders.
? Maintain ability to comply with business continuity plan (i.e. Work remotely)
? Provide input and participate in writing procedures and other documents


Role Requirements:
• Bachelor’s degree (BS) in a relevant discipline i.e. engineering, packaging/labeling
• Minimum 3-5 years of experience required working in a quality system within a regulated environment.
• Experience with the design and implementation of UDI for medical device units
• Must have knowledge and experience of quality system elements and how they interact – direct Global UDI system experience preferred.
• Must have experience and knowledge of how to determine the feasibility of adding GS1 UDI to a device, including experience of UDI labeling requirements and practical considerations.
• Must be knowledgeable of Global UDI and GS1 standards and requirements
• Requires a high level of attention to detail, and project management skills.
• Requires working knowledge of Barcoding systems and UDI requirements
• Requires knowledge of label printing applications and ERP systems

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204861106977536

LOCATION:

Illinois / United States

CITY:

Abbott Park

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Labeling Specialist - Quality    Apply

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Labeling Specialist
Pay Rate: $41.16/HR


The UDI Labeling Quality Control Specialist will support the review and implementation of quality system elements and product labels with respect to compliance with Global UDI requirements. This role will operate as a key team member of a focused team implementing Global UDI infrastructure across key Rapid Diagnostics (ARDx) sites (virtual visits). At each site, this team will work
with various functional teams (R&D, marketing, regulatory, quality, engineering, manufacturing) on quality system elements and labelling requirements and analysis related to global UDI Implementation for medical devices

Essential Duties and Responsibilities (Key Activities)
? Carries out duties in compliance with established business policies and procedures.
? Responsible for exhibiting professional behavior with both internal/external business associates
that reflects positively on the company and is consistent with the company’s policies and
practices.
? Responsibility to understand and maintain awareness of the quality consequences which may
occur from the improper performance of their specific job.
? Assist Project Manager as a Tiger Team Member in daily activities related to the UDI
implementation and maintenance activities, as assigned.
? Quality Management System Alignment: Review and redline legacy site quality management
system documentation to align with Divisional Global UDI SOP requirements.
? Label Verification: Ensure data accuracy between labels and master UDI data and global UDI
labelling requirements consistently implemented.
? Works with other functions to identify and resolve labeling inconsistencies with UDI
requirements in order to meet project objectives. Redline and update labelling, as required.
? Manage UDI label change controls to plan, prepare and submit complete and accurate change
requests within a PLM system/ Abbott’s Agile Quality Management System. While ensuring
correct implementation strategy is applied
? Support Project Manager during project execution with various data related needs.
? Collaborate, communicate, and provide status to key stakeholders.
? Maintain ability to comply with business continuity plan (i.e. Work remotely)
? Provide input and participate in writing procedures and other documents


Role Requirements:
• Bachelor’s degree (BS) in a relevant discipline i.e. engineering, packaging/labeling
• Minimum 3-5 years of experience required working in a quality system within a regulated environment.
• Experience with the design and implementation of UDI for medical device units
• Must have knowledge and experience of quality system elements and how they interact – direct Global UDI system experience preferred.
• Must have experience and knowledge of how to determine the feasibility of adding GS1 UDI to a device, including experience of UDI labeling requirements and practical considerations.
• Must be knowledgeable of Global UDI and GS1 standards and requirements
• Requires a high level of attention to detail, and project management skills.
• Requires working knowledge of Barcoding systems and UDI requirements
• Requires knowledge of label printing applications and ERP systems


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