|Title:||Document Control Coordinator|
Act as a site focal point for processing Engineering Change Orders and coordinate with other functions (Mfg.Eng., Supply Chain, Quality, etc.) and sites to ensure efficient release and change order processing.
Review Change Orders for content accuracy and completeness.
Support all release and change activity for new and existing products plus other controlled
Support various departments at site. Answer questions and resolve documentation issues as they
Represent Document Control as needed in internal and external audits (ISO FDA etc.).
Perform data entry into the PLM MRP system as required (Including New catalogue and Item numbers Bills of Material Routers Change Orders).
Manage Work Flow and obtain approval of Engineering Change Orders and Deviation and Item Master Changes.
Scan documents as needed.
Update Procedure Work Instructions Specification type word documents as required.
Maintain the Master Documentation files.
Monitor the status of employee training to ensure that controlled documents are only released when applicable training requirements are met.
Audit applicable departments and their Document Control practices to ensure compliance with document labelling and change control procedures and policies.
Provide inter site coordination of Document Control Projects and issue resolution.
Participate and complete miscellaneous tasks and special projects as assigned.
Support and interface with the Document Control team and other departments as required.
All Other Essential Duties as directed.
Associates degree. Greater than 5 years experience in a Document Control related function. Familiar with Engineering release and Change Control process.
FDA and ISO experience. Medical device experience a plus.
Familiar with Engineering release and Change Control process.
General Office skills, strong experience using Microsoft Office - Excel, Visio, Word Power Point.
Knowledge and experience using MRP systems.
Good verbal and communication skills.
Interfaces well with others.
Previous work experience in Manufacturing or Quality.
Ability to work effectively on an independent basis with multiple projects simultaneously.
Well organized and detail orientated.
Ability to problem solve and make independent decisions.
Team player interfacing well with others.
Detail oriented and attention to detail.