Quality Labeling Engineer

Rancho Cordova - California - United States - Life Sciences & Health Care - Medical devices - Project Management & Services - Academic Bachelor

We’re hiring a Quality Labeling Engineer for our client, a successful medical devices company, based in Rancho Cordova, CA.

This individual will utilize Graphic, Labeling and Barcode software to develop labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP’s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. They must have demonstrated capability and experience in role.

They will also develop formal label request process, implement project management tool such as Monday.com to coordinate incoming requests, establish objectives and provide accurate resource assessment to drive deliverables on time.

Feel free to contact

Sinead McLaughlin, Account manager

Apply now

About this role

Responsibilities

  • Develop and maintain Instruction For Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy.
  • Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats.
  • Use of PLM (Windchill) for document control process to route all work for approval
  • Perform prepress activities necessary to prepare labeling artwork files for accurate output.
  • Prepare and route labeling packages for 1st article and approvals.
  • Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices, which focuses on a first-time right approach. Attention to detail with minimal errors is key.
  • Reviews and updates as necessary to ensure proper revision control and storage of all labeling.
  • Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments.
  • Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments.
  • Can successfully work with cross-functional teams to address NCRs and CAPAs. Investigate, analyze, and identify root cause. Evaluate underlying issue and find long-term solutions.
  • Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes.

About you

Requirements

  • Bachelor's Degree or equivalent
  • Previous experience working on labeling for medical devices from a regulatory standard.
  • Knowledge of Regulatory standards (FDA, EU MDR, Japan, Canada, ISO standards)
  • Strong understanding of labeling regulations and requirements, experience with label localization thorough understanding of US labeling regulations
  • Ability to manage multiple projects with strong emphasis on exceeding customer expectations with the "first time right" mindset.
  • Computer/software proficient: Microsoft Office, Adobe (lifestyle), SAP, Windchill
  • Great communication both written and verbal

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB250351
  • Location: Rancho Cordova
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Medical devices
  • Education level: Academic Bachelor
  • Area of Expertise: Project Management & Services
  • Closing date: Monday, March 9, 2020
Apply now

Feel free to contact

SM

Sinead McLaughlin

Account manager Brunel Energy Canada Calgary

+1 403 539 5009

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