Specialist, Document Control
Integra LifeSciences - Austin, TX

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Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery.
Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, tendon and peripheral nerve protection and repair, and wound 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 is also 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 3,000 employees worldwide. For the last three years, Integra has been included in NJBIZ's list of "New Jersey's 50 Fastest Growing Companies." In 2010, we were also included in Forbes magazine's "America's 100 Best Small Companies".
We value innovative thinkers who are open to new opportunities and derive satisfaction from knowing that their efforts are making a difference in someone’s life.
Detailed Description This position is responsible foradministrating the quality document management program by establishing andmaintaining a Quality Assurance (QA) document records program which consists ofa systematic approach by which records are properly assessed reviewed, changed,controlled, distributed, retained and archived. Responsible for identifying, addressing and processing the life cycle ofall documents, which includes development of a tracking system and controllingthe retention of all documents. Thisposition will also provide direct support to quality assurance andmanufacturing functions and will support the continuous improvements with theQA department.
Job Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this jobsuccessfully, an individual must be able to perform each essential dutysatisfactorily. Assist with maintaining the electronic document control system Process all documents changes as required Organize, maintain, and control documents so that they are easily retrievable both electronically and manually Assist with revising department procedures as needed Review and proofread documents for consistency prior to routing Coordinate the communications of product changes to suppliers as needed Coordinate the communication of quality system document changes/additions to employees as needed for training purposes Coordinate calibration activities and maintain those records for all on-site and off-site equipment Assign unique identifiers and maintain a list of all production/test equipment Coordinate bioburden testing and sterility dose audits and maintain those records Coordinate cleanroom environmental monitoring activities and maintain those records Provide support to manufacturing by performing sterilization release, Device History Record review, and development of manufacturing conformity declarations statements Assist with training personnel on Document Control processes Submit department performance data for trending and data analysis Support Internal, external, and regulatory audit activities Maintain and revise the external standards list as required Other projects as assigned by manager
DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of theknowledge, skill, and/or ability required for this position.
  • Education: A high school diploma or equivalentis required with a minimum of one year of experience in computer applicationswithin a quality system. Work experiencewill be considered in lieu of higher education.
  • Solid work ethic
  • Ability to work independently, multi-task andprioritize
  • A working knowledge of the general applicationof FDA and/or quality system terminology/regulations is preferred.
  • Working understanding of information management and record keeping
  • Excellent interpersonal skills. Must be able to work in a team environment
  • Excellent written communications, timemanagement, administrative and organizational skills
  • Detail oriented
  • Good problem solving skills
  • Computer literate
  • Willingness to travel (< 10%)
How To Apply We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.
To find out more about our company, visit our website at: http://www.integralife.com/Careers/
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V
Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.
Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.

Integra LifeSciences - 22 months ago - save job - block
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About this company
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When it comes to regenerative medicine, Integra LifeSciences is integral to the healing process. Using its proprietary collagen matrix...