Integra LifeSciences QA Specialist in Boston, 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.
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 4,400 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!
Writes and revises operating procedures
Conducts training for staff at all levels as it relates to quality systems
Processes document change requests
Processes and files training records
Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management
Compiles information for Quality Management Review
Conducts inspections of materials
Reviews records for compliance such as inspection reports, test records, and Device History Records
Updates component, product, and documentation databases
Reviews validation/qualification reports for GMP and quality system compliance
Conducts complaint investigations
Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews
Investigates and reviews Nonconforming Material reports and presents reports/metrics during periodic meetings
Evaluates supplier quality performance and conducts periodic evaluations of suppliers
Conducts internal audits
Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses
Other duties may be assigned as necessary
Associate’s Degree in a Science related discipline required. A Bachelor's Degree preferred.
1-3 years’ experience in a Quality/Regulatory Compliance environment. Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Moderate experience in computer software applications such as Outlook, PowerPoint, Word, Excel
Ability to follow instructions precisely, recognize deviations, and recommend corrective action
Exercises sound judgment and decision making when problem solving
Vacancy ID 2018-27478
Position Type Regular Full-Time
Category Quality Assurance