Specialist, Labeling Design - Aliso Viejo, United States - MicroVention, Inc.

MicroVention, Inc.
MicroVention, Inc.
Verified Company
Aliso Viejo, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
Design, develop and update global labeling documents to include product labels, instructions for use (IFUs), implant cards, specifications and technical documentation


Job duties:

  • Designs, develops and implements changes to new and existing product labels and instructions for use (IFUs).
  • Collaborates with labeling change request initiators to understand requirements, design solutions, timelines and deliverables.
  • Creates databased labels, static preprinted labels, IFUs and implant cards using labeling software.
  • Develops standardized and optimized label templates and identifies issues associated with design.
  • Ensures labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures and work instructions.
  • Effectively collaborates with crossfunctional groups and stakeholders for successful implementation of labeling designs and changes.
  • Coordinates with suppliers and vendors for outsourced printed products and translated materials.
  • Supports investigations, root cause analysis and corrective action to address labeling nonconformances.
  • Supports labeling initiatives collaborating with individuals from functional groups to provide solutions and meet objectives.
  • Performs other responsibilities as assigned.

Job Details:

Job ID 12204BR

Aliso Viejo, California, USA


Salary Range:
$80/hour

  • Qualifications
  • Bachelor's Degree in related field or equivalent experience.
  • Three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation.
  • Three (3) years of experience in labeling and digital design software platforms, including labeling database management.
  • High level of attention to detail and sustained focus.
  • Project management skills and experience.
  • Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.
  • Good problemsolving, organizational, analytical and critical thinking skills.
  • Ability to work in a crossfunctional environment while building positive internal/external working relationships.
  • Good written and verbal communication skills.

Desired Qualifications

  • Extensive knowledge and efficient use of digital labeling design software platforms (e.g., Teklynx Central, Teklynx Codesoft, Adobe Creative Cloud, Illustrator, InDesign and Photoshop).
  • Moderate knowledge of document management systems (e.g., EtQ Reliance).
  • Ability to perform minor level tasks in SOLIDWORKS.
  • Basic knowledge of FDA and global regulations as it relates to labeling requirements and documentation.
  • Understanding of domestic and global labeling implementation.
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