Manager, Document Control

Duties and Responsibilities

The Document Control Manager is responsible for administering the company's controlled documents in accordance with company requirements.
Establish and maintain procedures for maintaining documents and change control of documents.
Determine and enforce, through functional groups, document control requirements to ensure the company meets internal and external needs.
Evaluate and develop improved techniques for the control of documents. Is directly responsible for implementation, administration and maintenance of the document control system.

Reports on the performance of the document control system for review and as a basis for improvement of the document control function.
Supports configuration and change control, data management, new product introduction, sustaining engineering and production projects and process analysis for quality initiatives.
Performs other duties consistent with the position, as required or assigned.

Minimum Education

The Document Control Manager should have a four year technical degree or equivalent education and work experience preferably in a field that offers an opportunity to gain a well rounded background. Additional training in Document Control (i.e. courses/seminars in Engineering Change control and Engineering Change Requests, is preferred.)

Desired Training and Experience Required

• Thorough understanding of of FDA regulations(QSR) and ISO 13485:2003 standard.
• 5 years of broad Document Control experience. 2 years minimum experience in managing technical documentation, Engineering change release management and administration of Change Control Board process.
• Prior experience with Agile, PDM systems is preferred. Experience with ERP systems is also preferred.

Compensation: The anticipated range for this position is $99,000 - $149,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.