Integra LifeSciences Coordinator, Document Control in Cincinnati, Ohio
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.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Effectively being responsible for the implementation of document control processes for all Integra LifeSciences Cincinnati site documentation.
Primary responsibilities are to:
Change Control, Control of Documents and Distribution
Ensures change control compliance, by reviewing completeness, accuracy and proper document approval of documents and quality system records.
Confers with document originator and approvers in a positive, collaborative manner to prepare controlled documents which conform to Integra’s defined format.
Process change control packets or release of organizational procedures for Quality System documentation, including but not limited to Standard Operating Procedures, Work Instructions, forms Engineering Orders, Device Master Record, Labeling, Validation Reports, Deviations, and other quality records.
Chairs Change Control Board (CCB) in Agile.
Tracking of Implementation Plans.
Represent Document Control in project meetings as required.
Maintains master files for quality system documentation.
Manages issuance of document and or tracking numbering systems governed by Document Control.
Manages and coordinates the timely release of controlled quality system document distribution and assures obsolete documents are promptly removed from all points of use or otherwise prevented from unintended use.
Manages and maintains archives and retrieves applicable on-site and off-site quality system records per record retention policy.
Support certificate requests.
Assist with internal audits.
As Back Room Support, review and provide documentation to Front Room during External Audits.
Prepare technical drawings such as blueprints used to build product.
Other duties may be assigned as deemed necessary by the supervisor.
High School diploma
Minimum of 2 years’ experience with Quality System Documentation and good documentation practices
Knowledge of ISO, FDA and GMP concepts and guidelines
Knowledge of HIBCC barcode standards
Proficiency in Microsoft Word, Powerpoint, and Excel
ERP System working knowledge (Agile and Oracle experience preferred)
Basic knowledge of CAD software (SolidWorks preferred)
Knowledge of SharePoint
Labeling software (i.e. Bartender, Loftware)
Must be well organized and self-motivated
Must be able to handle multiple projects concurrently
Must be detail-oriented, dependable and trustworthy
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, fax, scanner and copy machine as well as other general office equipment. Strong computer skills are required.
Vacancy ID 2018-26976
Position Type Regular Full-Time
Category Quality Assurance