Document Control Manager

Document Control Manager – Medical Device Manufacturer

Agile Search is partnered with a global medical device manufacturing company

immediately seeking a high performing Document Control Manager to lead a team

that will be responsible for transitioning and upgrading the organization to a world-class,

integrated electronic document management system. This position is located at the

company’s headquarters near Mansfield, MA and will be mostly on-site, with occasional

remote working arrangements possible. In this role you will lead a team of Document

Control specialists and work cross functionally to support the corporate document

control system, quality management system and manufacturing compliance. This

global company offers a great work environment with a strong benefits package and

compensation plan.

Key Responsibilities:

Lead the implementation of and make recommendations for the transition and

improvement of the company’s Document Control Management System and

integration with the quality management system

Manage all aspects of the document control system to ensure ISO13485 and

FDA 21CFR820 compliance

Manage personnel, make staffing recommendations, and provide mentoring and

staff development

Manage, create, and make available all quality system control documentation

and records to ensure compliance to the medical device regulatory standards

Periodically review documentation to ensure consistency, and provide training if

necessary

Support Quality Management during audits

Desired Skills and Experience

Bachelor’s degree, associates or equivalent

5 years’ experience in document control with demonstrated success leading

quality initiatives and document control improvement initiatives

Experience in a leadership or management role with mentorship of others

Familiar with database creation in Visual Basic, Microsoft XML, and Java Script

Excellent written and communication skills

Ability to create and interpret quality summary reports, technical instructions, and

safety manuals

Experience and proficiency with Microsoft Office software