Job Details

Documentation Specialist(Santa Ana, CA 92705)

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Document creation and revision of procedures to manage compliance during transition process
• Document creation and revision of Division level procedures for each Quality subsystem
• Prepares, edits, files, assembles documentation such as reports or technical documents, records, or correspondence.
• Proofreading and verifying own work
• Verify integrity of Change Request packet
• Processing of controlled documents per approved change requests in Agile document management system
• Information mapping of documents
• Responsible for management of version control, resolutions of conflicting changes, and working closely with the document owners to assure all needs are met.
• Track document control and archival metrics for the department.
• Maintenance of documents per corporate record retention schedules
• Serving as the focal point for customer inquires for document requests/usage as it relates to Harmonized Quality System project
• Support initiatives which may include attendance at project meetings

*****5 years plus experience and medical device experience****