Integra LifeSciences

Quality Assurance Associate

Vacancy ID
2017-23727
US-TN-Memphis
Position Type
Regular Full-Time
Category
Quality Assurance

Overview

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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

 

It's a great time to join our growing company and become one of our impassioned colleagues making lives better for the patients we serve!

 

Responsibilities

  • Conduct review of product history records for accuracy and completeness, including adherence to Integra policies and procedures, cGTP, and FDA regulations as well as AATB Standards.
  • Conduct review of charts, donor eligibility system and coordinate review and release of donor charts with the medical director within standards established by the FDA, AATB, and Integra Life Sciences.
  • Assist with the development and oversight of the organization’s quality systems program.
  • Create, update and maintain Employee Training Plans. Evaluate technical staff on an annual basis for competency and conduct training as needed.
  • Perform and/or review the daily, weekly, monthly, quarterly, and annual preventative maintenance on all applicable equipment.
  • Audit freezers, refrigerators, freezer/refrigerator logs, chart wheels and temperature monitoring systems to ensure accuracy and compliance within standards established by the FDA, AATB, and BioDlogics, LLC.
  • Assist with vendor qualifications and complaint investigations.
    Assist with and review tissue disposition including returns and discards.
  • Maintain and review SDS and supplies/reagents receiving logs.
  • Assist with state licensure renewals.
    Review distribution packaging forms, lot detail log and packing list.
    Maintain knowledge of FDA, AATB and CDC/United States Public Health Services rules, regulations and standards pertaining to tissue donation and transplantation.
    Perform other duties as assigned

Qualifications

Minimum requirements

  • BS/BA in math, science, engineering or related technical field
  • Minimum of 3+ years' experience in an FDA regulated industry (medical device, pharmaceutical, biotech) 
  • Working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 and familiarity with ISO 14971

Preferred requirements

  • Advanced degree preferred
  • Strong organizational, leadership and interpersonal skills 
  • Analytical expertise and strong detail-orientation
  • Excellent communication skills, both written and verbal
  • Ability to effectively prioritize and lead multiple activities and responsibilities is required

 

 

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