Quality Administrator

RR DonnelleyPlover, WI
Onsite

About The Position

This role ensures that all operational and quality documentation—including specifications, procedures, and training records—is accurate, up-to-date, and readily available to support production and regulatory requirements.

Requirements

  • Associate's Degree in related field
  • At least 2 years of relevant experience
  • Exceptional accuracy in data entry and document review, particularly in a regulated manufacturing environment.
  • Strong written skills for drafting procedures and the ability to coordinate across multiple departments (Production, Quality, and Leadership).
  • Ability to pull and interpret data for weekly compliance reporting.

Nice To Haves

  • Prior experience with document management software is highly preferred.
  • Familiarity with ISO 13485:2016 is highly preferred.

Responsibilities

  • Upload and categorize various document types, including customer BOMs, specifications, standard operating procedures (SOPs), and forms.
  • Perform detailed reviews of all documents prior to upload to ensure formatting, versioning meet established SOP requirements.
  • Conduct rigorous reviews of submitted documents to ensure compliance with site formatting and naming conventions before they are made live in the system.
  • Create item set up in the ERP system based on specifications provided by the customer.
  • Provide control-stamped specifications and procedures to the Operations Scheduling team and Production leads to ensure floor-level compliance.
  • Provide "second signature" verification for First Article Inspections (FAI) and Device History Records (DHR) , serving as a critical check to ensure all quality criteria have been met before moving to the next stage of production.
  • Manage and maintain EtQ training records for all Plover employees, ensuring 100% data integrity for regulatory audits.
  • Generate and distribute weekly status reports to the supervisor team highlighting upcoming or overdue training requirements.
  • Proactively rewrite training procedures as needed to streamline how training completion is captured and documented, making the process more intuitive for employees.
  • Act as a versatile resource for Quality Specialists and Quality Technicians , assisting with data collection, audit preparation, and technical documentation tasks.
  • Complete cross-training withing the Quality team, as directed, to ensure consistent coverage for all tasks.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Associate degree

Number of Employees

5,001-10,000 employees

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