Integra LifeSciences QA Specialist in Boston, Massachusetts

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 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!

Responsibilities

  • 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

Qualifications

  • 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

  • Detail-oriented

Vacancy ID 2018-27478

Location US-MA-Boston

Position Type Regular Full-Time

Category Quality Assurance