At Zebra, the business problem is to maintain a Quality Management System, including management of areas such as Change Control, Document Control, Calibration, and Basic Data in the ERP system, to ensure the quality of products and services.
Requirements
- Control software (for document control)
- ERP System
- ISO and/or GMP experience is preferred
- Knowledgeable math ability in the use of statistical methods, ability to interpret graphs and communicate results
- Ability to read and interpret data, including graphs, as they relate to test results.
- Ability to collect pertinent data, establish facts, draw conclusions and identify problems
- Good verbal and written communication skills necessary
Responsibilities
- Acts as an informal leader, may deputize in their supervisor’s absence. Regularly trains new employees on department, ISO, and GMP procedures
- Responsible for the maintenance of Quality System procedures and work instructions
- Supports the Change Control process: revises documents and processes, tracks open changes, maintains records for all changes, maintains all controlled copies (ie. filing, distributing, destroying), and prepares metrics on the process.
- Independently maintains inventory of approved artwork binders and numbered lab notebooks
- Facilitates vendor evaluation process by maintaining all vendors checklists and by ensuring vendor ISO certificates are current and on file.
- Performs internal audits and write audit reports. Prepares CAPA’s for audit findings.
- Manages ERP Basic Data for new/existing parts
Other
- Two or Four-year degree or equivalent
- 4+ years of relative work experience
- Minimum three years quality management system experience
- Good writing skills, and word processing
- Ability to use spreadsheets (Corel & Excel)