Senior Labeling Systems Technical Specialist

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

POSITION SUMMARY

Key labeling role that specializes in Labeling Program Management, labeling business process updates, and Airlife’s labeling technical expert of labeling software’s. This position will lead Loftware Spectrum Integration globally across all sites to final completion.  This position will be the technical expert on all labeling solutions globally and support in training activities with labeling team members from creation of labeling to printing labeling at manufacturing sites. This person will create and maintain all labeling processes globally and at a site level.

POSITION QUALIFICATIONS

Knowledge: 

• Labeling Software Expert (specifically Loftware Spectrum). 
• Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
• Strong communication skills; both oral and written. 
• Strong project management skills including stakeholder management.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.

Level of Experience: 

• 3+ years relevant medical device industry experience. 
• 3+ years working with labeling systems (Loftware Spectrum, Bartender, etc).
• Applied knowledge of FDA Labeling requirements.
• Experience with barcoding and UDI compliance.

Level of Education: 

• Bachelor or Associates Degree and/or equivalent work experience. 

Travel:   

10-15%. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Act as business process owner for labeling processes and assume role of documentation subject matter expert.  This would include:   
  • Maintaining and updating global labeling processes. 
  • Lead global Subject Matter Experts (SME) forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders. 
  • Stay up to date with regulatory labeling standards and update processes as required. 
• Loftware Spectrum Integration Program Manager 
  • Be the program lead of the Loftware Spectrum Integration project to full completion and manage timeline(s) to full completion.   
  • Fully train employees globally on the Loftware Spectrum Labeling solution.
  • Create, identify, and report on labeling metrics weekly/monthly reading the Loftware Spectrum Integration project.
• Global labeling technical expert (specifically Loftware Spectrum).
• Label Maintenance (SQL server database) SME. All label data is stored in the Labeling Maintenance server.  
• Manage global printer lists. 
• Maintain software licenses and invoices.

OTHER RESPONSIBILITIES

• Focus on achieving our Company mission. 
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety. 
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise.   It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.