Zimmer Biomet Parsippany , NJ 07054
Lead the Document Control group. Coordinate review and storage of device history documents, including Work Orders, Specifications, Reports and other documentation related to production, inspection and shipping of product.
Manage the training system for the site. May also assist with various projects.
Principal Duties and ResponsibilitiesCoordinate quality and production related tasks for the Document Control Group
Responsible for maintaining and sustaining the site's change control, training and documentation processes and supporting all related activities in accordance with Zimmer Biomet procedures and applicable regulations.
Manage the change control system; review and release change orders
Document maintenance and storage includes: Sterile and non-sterile product release, devise history review and release, engineering drawings for facilities, database entries, test sample coordination, label tracking and other related documents.
Monitor status of in-process document changes to ensure timely revisions.
Distribute revised documents as needed, both internally and externally.
Create/update custom labels for packaging.
Coordinate with appropriate resources for required translations.
Assist with audits by locating necessary documents in system(s).
Assist with purchasing office supplies.
Trains and supports other personnel (as their job relates to DC)
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of CompetenceStrong customer focus and good interpersonal skills.
Ability to balance multiple projects and goals, while facing strict deadlines.
Ability to maintain compliance to all applicable procedures and regulations
Ability to maintain multiple reports, tables and indices.
Ability to maintain electronic documents, such as: Validation Records, Design History Files, Manufacturing Transfer Records and Risk Management files.
Education/Experience RequirementsHigh School diploma or equivalent required. Additional education helpful.
Minimum 5 years related experience in a regulated quality environment
Experience with JDE and familiarity with the Zimmer Biomet QMS System preferred
Travel Requirements< />