Integra LifeSciences Quality Control Analyst I 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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

  • Perform chemical assay of solutions as well as general laboratory maintenance

  • Microbiological testing

  • Inspection and testing of raw materials, intermediates and final product

  • Environmental monitoring of clean rooms and water system

  • Develops and revises SOPs and trains appropriate employees

  • Maintains a working inventory of all components and archived materials and solutions

  • Writes and executes testing studies of finished products and components

  • Assist as needed in test method validation, implementation, and execution

  • Provides database support, generate reports and analyze process data

  • Assists Quality Assurance in document review and revision

  • Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)

  • Investigates and reviews Nonconforming Material reports

  • Assist in preparing for and participating in FDA audits, customer audits, etc.

  • Demonstrate excellent organizational and time management skills

  • Perform other duties as required

Qualifications

  • Bachelor’s degree in the biological or chemical sciences or equivalent

  • 1 - 3 years experience in medical device, pharmaceuticals, or other regulated product preferred

  • Working knowledge of standard laboratory practices and safety

  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action

  • Exercises sound judgment and decision making when problem solving

  • Detail-oriented

  • Experience working in ISO Class 7 cleanrooms preferred

  • Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations

Vacancy ID 2018-27006

Location US-MA-Boston

Position Type Regular Full-Time

Category Quality Assurance