Integra LifeSciences Document Control Coordinator in Raynham, Massachusetts
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has nearly 4,000 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Integra LifeSciences has entered into an acquisition agreement of Codman Neurosurgery. This transformational acquisition creates compelling value for our shareholders, employees and patients, andenhances our global position in neurosurgery by adding a complementary product portfolio and the world-recognized Codman brand. This expansion position is open as a result of this exciting acquisition.
This position serves as a Document Control Coordinator for the Mansfield, MA facility, responsible for control and maintenance of all relevant quality system documentation, including standard operating procedures, work instructions, forms, and external standards.
Under direct supervision of the Site lead
None; Individual Contributor.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for supporting the maintenance of the document control system
Responsible for formatting, proper spelling and clarity of text for any written documents submitted to document control
Review all electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
Maintains all ISO/FDA standard operating procedures, work instructions and forms
Maintains revision and approval status of all documents
Maintains official copies (either hard copy or electronic) of all approved documentation
Maintains appropriate form templates for access
Updates computerized documents with data from change control documents and maintains archive of changed ISO/FDA controlled documents
Manages circulation of documents for management approval
Act as contact point for Corporate for the issuance of new or revised corporate policies and procedures
Tracking, follow-up and implementation of, including but not limited to, ECOs, validation records, batch records and notebooks.
Responsible for supporting record retention activities (collection, shipment and retrieval to/from offsite storage)
Minimum of 1-2 years’ experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage
Minimum of 1-2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred
Capable of both written and verbal effective communication skills including presentations as assigned.
Proficient in the Microsoft Office suite of products.
Solid organizational and document management skills
Vacancy ID 2017-22322
Position Type Regular Full-Time
Category Quality Assurance