Integer

Integer

Engineer II - Labeling (Remote)

Remote - United States · Mid

Sponsorship not specifiedDetected 6 days ago
IllustratorInDesignCustomer SupportGMPFDA RegulatoryCommunicationCollaborationTime ManagementMicrosoft Office

About the role

  • Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance.
  • Employees are immediately eligible to participate in the 401(k) plan with company matching contributions.

Responsibilities

  • Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life cycle. Tracks and maintains labeling documents using process tools for revision control.
  • Reviews labeling documents to ensure accuracy, including formatting of text and graphics conform to established guidelines for consistency, technical construction, and overall presentation.
  • Initiates and/or implements Change Control Requests pertaining to labeling updates. Follow through on open Change Control Requests and evaluate the impact assessment related to labeling updates.
  • Performs upload and maintain the applicable UDI databases (i.e. FDA UDI GUDID, EUDAMED).
  • Investigate, contribute and support new labeling process technologies of moderate scope.
  • Executes new labeling in support of new product development and current production. Collaborate with cross-functional teams to ensure labeling deliverables are on-track with each project.
  • Prepares and manages labeling translations activities.
  • Supports the execution of Packaging and Label Validation Plans and Reports.
  • Ensures packaging and labeling follows regulatory, customer and specification requirements and standards. Provides support with internal and external Regulatory submission package.
  • Supports the validation of packaging equipment and labeling equipment to include IQ, OQ and PQ.

Requirements

  • Bachelor's degree in a related field or 3+ years of experience of GMP, FDA, Change Control process
  • Collaborates with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
  • Performs other duties as required.

Skills

  • Strong written and oral communication skills.
  • Strong attention to detail.
  • Strong organizational and time management abilities
  • Strong understanding of Regulatory labeling landscape.
  • Specialized Knowledge:
  • Strong proficiency with Microsoft Office
  • Strong proficiency with Adobe InDesign
  • Strong proficiency with Adobe Illustrator
  • Knowledge and understanding of label creation software
  • U.S. Applicants:
  • Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.
  • Parental leave is available after one year.

Compensation

  • Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy.

Benefits

  • Education & Experience:

Company info

  • By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
  • At Integer, our values are embedded in everything we do.
  • We focus on our customers' success
  • We create better solutions
  • Collaboration
  • We create success together
  • We always interact with others respectfully
  • We are open and honest with one another
  • We do the right things and do things right
  • Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope.
  • Communicate with internal and external customers regarding ongoing labeling updates.

Equal opportunity

  • In addition, veterans and individuals with disabilities are encouraged to apply.
  • Equal Opportunity Employer.
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This listing is sourced directly from Integer's careers page and normalized into a canonical job model.