PURPOSE OF JOB: Completes a wide variety of assignments under
general supervision within the scope of medical device document
control. These assignments include support of electronic and manual
record management activities such as word processing, archival,
retrieval, records modification, and verification. Works under
normal supervision on routine work and received detailed
instructions and oversight on new assignments. Performs all
responsibilities in compliance with company policies and
1. Leads and maintains the change control process. This includes
the preparation of the change requests, insuring the appropriate
functional reviews and sign-off, and maintaining the records of the
changes. Posts changes to computerized or manual files, releases
documents, and notifies affected departments.
2. Maintains an established data distribution system and expedites
review, signature approval and release of documentation in a timely
3. Analyzes and develops recommendations to improve documentation
4. Responsible for maintaining the Expandable ERP documentation
database and the change control database
5. Administration of the training effectiveness program, including
data entry/maintenance, tracking, and reporting.
6. Confers with change originators to prepare documents and change
requests. Works with document originators to resolve discrepancies
in order to make required changes to the documentation.
7. Responsible for maintaining the existing record retention
8. Participates in the creation of new processes and revision of
existing processes to improve the Quality Management System.
9. Organizes and maintains active, obsolete, and computerized files
which support the documentation system, including device master
records, design history records, and labeling.
10. Support various special projects support for regulatory
compliance and to meet company-wide quality objectives.
1. Interface with other Company departments as required.
2. Assist in compilation and preparation of information for various
summary reports, including complaint and NCR summaries, for quality
system management review or as otherwise required.
3. Assist in third party inspections and audits, and internal
4. Provide controlled documents to other departments as
5. Maintain professional and technical knowledge by continuing
6. Perform other responsibilities as assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
1. Possesses willingness to learn complex subjects with a minimum
of instruction and/or supervision.
2. Possesses working knowledge of computers (word processing,
spreadsheets, databases, etc.).
3. Minimum of high school diploma, with a bachelor's degree
preferred, and one to two years' experience, preferably in the
medical device industry in Engineering-related or Document Control
4. Ability to read and develop technical drawings or prints.
5. Must be a self-starter and hands-on, with excellent
organizational, oral, and written communication skills.
We are an equal employment opportunity employer and will consider
all qualified candidates without regard to disability or protected