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