Quality Administrator
Plover, WI - USA
Job Summary
This role ensures that all operational and quality documentationincluding specifications procedures and training recordsis accurate up-to-date and readily available to support production and regulatory requirements.
Responsibilities:
Document Management & Change Control
- 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.
Operational Support
- 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.
Training & Compliance
- 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.
Qualifications :
- Associates Degree in related field
- At least 2 years of relevant experience
- Prior experience with document management software is highly preferred.
- Familiarity with ISO 13485:2016 is highly preferred.
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.
RRD is an Equal Opportunity Employer including disability/veterans
Remote Work :
No
Employment Type :
Full-time
About Company
RRD is a leading global provider of marketing, packaging, print, and supply chain solutions that elevate engagement across the complete customer journey. The company offers the industrys most trusted portfolio of creative execution and world-wide business process consulting, with ser ... View more