Document Control Job Code 07-999

San Marcos, California 

DOCUMENT CONTROL/ CONFIGURATION MANAGEMENT

The successful candidate must have a thorough understanding of documentation requirements in accordance with ISO 9001:2000 – Quality Management Systems and 21 CFR Part 820 – Quality System Regulation.

Position Summary:

Responsibilities will include the maintenance of documentation required for FDA and ISO compliant manufacturing.  Implementation of policies needed to organize and maintain records, both electronic and paper. Chairperson for all Change Control Board (CCB) activities.  Maintain the document change control processes that involve the receipt, maintenance, approval, incorporation, effectivity of change, distribution, and storage of documents.  This responsibility includes, but is not limited to; product specifications, customer specifications, standard operating procedures, manufacturing instructions, validations, protocols, deviations, investigations and standard QMS templates/forms.  Maintain configuration control of all build documentation.  Responsibilities will include control of as-built configuration documentation, device history records (DHR), etc.  Department responsibilities include data entry, maintenance and revisions to product “bill of materials” for manufactured products.  Ensures that all changes to documentation are implemented in an accurate and timely manner

Position Qualifications:

Minimum five years experience involving document control activities. 

Excellent communication skills are required. 

Ability to effectively communicate directly with all levels of personnel

Excellent attention to detail, high word processing accuracy

Must exhibit computer proficiency with Microsoft Office, Excel, Access, etc.

Strong organizational skills

Strong self-motivation and ability to work under limited supervision

 

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