Integra LifeSciences

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Quality Assurance Specialist

Quality Assurance Specialist

Vacancy ID 
Position Type 
Regular Full-Time
Quality Assurance

More information about this job


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."


  • Conduct release and closure reviews of product history records for accuracy and completeness to ensure adherence to Integra Life Sciences policies and procedures, both at site and global levels, cGTP and FDA regulations, andAATB Standards.
  • Conduct donor record reviews according to the standards established by Integra Life Sciences in accordance with FDA and AATB regulations before submission to the medical director for donor eligibility determination.
  • Assist with the development and oversight of the site’s quality systems program.
  • Create, update and maintain employee training plans. Evaluate technical staff for competency of role assigned on an annual basis. Conduct training as needed.
  • Perform and/or review the daily, weekly, monthly, quarterly, and annual preventative maintenance on all applicable equipment.
  • Audit freezer/refrigerator logs, chart wheels and temperature monitoring systems to ensure accuracy and compliance of standards established by the site in accordance with the FDA and AATB.
  • Assist with vendor qualifications.
  • Assist with complaint investigations.
  • Assist with and review tissue disposition including returns and discards.
  • Maintain and review SDS and supplies/reagents receiving logs.
  • Review distribution packaging forms, lot detail and packing lists.
  • Maintain knowledge of FDA, AATB, and CDC/United States Public Health Services rules, regulations and standards as each pertains to tissue donation, distribution and transplantation.
  • Perform other duties as assigned.


Minimum requirements

  • Minimum of 1+ year experience in an FDA regulated industry (medical device, pharmaceutical, biotech, tissue banking, etc.) 
  • Working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 or similar 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



Preferred requirements

  • BS/BA in math, science, engineering or related technical field. Advanced degree preferred
  • 3+ years experience in an FDA regulated industry

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