Document Control Specialist

Sturtevant, Wisconsin | March 29, 2019

Essential Duties and Responsibilities:

  • Read and understand engineering drawings and schematics
  • Maintain records database including internal and external specifications, batch records, ECNs and other records of the quality management system
  • Create, review and revise documents of the quality management system, including (but not limited to) Procedures, Work Instructions, Control Plans and Forms
  • Maintain Training files
  • Participate in New Employee Orientation as GMP Trainer
  • Maintain electronic records and updates
  • Must be organized, thorough, and have excellent communication throughout all plant levels
  • Communication with customers and suppliers as needed
  • Qualifications:
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be able to read and interpret engineering drawings, schematics, and specifications
  • Must have a sound understanding of ISO 13485, 21 CFR820
  • Education and/or Experience:  
  • High School diploma/GED required
  • Associates Degree in a Science or Technical field (preferred)
  • 1 – 2 years of experience in a regulated industry
  • Experience with silicone rubber a plus