Labeling Quality Specialist

Who is Drive DeVilbiss…

 Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 80 countries around the world.   

 “Leading the World with Innovative Healthcare Solutions that Enhance Lives”

 Summary (Major Purpose of the Role): We are seeking a talented and meticulous Labeling Quality Specialist to join our team. This role supports the routing, coordination, and approval of the packaging and labels. To succeed in this role, you will have a strong diligence and an analytical mindset. You will collaborate with cross-functional teams, including marketing, product management, sourcing, engineering, and regulatory teams to ensure that our packaging designs meet regulatory requirements and accurately communicate product information to the end-user.

Main Activities/Responsibilities:

• Facilitate and manage the routing of packaging artwork for approvals across all departments while adhering to the established processes.
• Responsible for final product labels review and approval throughout the label/packaging approval process.
• Ensured accurate printed information on labels in compliance with regulatory requirements for medical devices.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews, and updates SOPs as required.
• Conducts plans and actions to support new medical device product launches, new market and other quality management activities as assigned.
• Provides support during internal audits, health authority inspections and external audits.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintain strong attention to detail throughout the new product development to review label design, from concept development to final production, to ensure that packaging designs meet standards and regulatory requirements.
• Collaborate with external vendors/factories to implement packaging and labels as required
• Develop and improve label issuance processes to drive operational efficiency
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.

Education and Experience:

• Bachelor’s degree in graphic design, Packaging Design, or a related field.
• Minimum of 3 years of experience in packaging and label design, preferably in a regulated industry such as medical devices or pharmaceuticals.
• Industrial or consumer packaging experience.
• Familiarity with compliance to government regulations.
• Knowledge/competence in Adobe Creative Suite (Illustrator, Photoshop, InDesign).  Corel Draw is a plus but not required.
• Experience with labeling and regulatory compliance requirements, including FDA regulations and ISO standards.
• Strong project management skills, including the ability to manage multiple projects simultaneously and meet tight deadlines.
• Solid understanding of packaging materials, printing techniques, and production processes.
• Keen eye for detail, color, typography, and layout.
• Ability to work under pressure, manage multiple projects simultaneously, and meet tight deadlines.
• Highly organized and detail orientated to ensure output accuracy.