Integra LifeSciences

Quality Assurance Engineer II

Vacancy ID
2017-23757
US-TX-Austin
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

  • Participate in the initiation and launching of new or improved product/processes, and the transfer of technology from development to commercialization from a quality and manufacturing perspective.
  • Assist with the development, approval, and execution/implementation of new and updated operational procedures/documents such as validation protocols/reports, risk documentation, Quality/Manufacturing procedures, product and material specifications, Quality Plans/Reports, SOP’s, work instructions, and other corporate initiated project documents.
  • Ensure that all projects and procedures are in compliance with GLP, QSR, ISO or other applicable requirements.
  • Assist with the oversight of the non-conforming material process and facilitate the Material Review Board meetings.
  • Aid in the implementation of statistical based sampling plans and other statistical controls into the manufacturing processes.
  • Measure and report out metrics and trends to appropriate management/teams.
  • Coordinate and conduct activities required by the calibration and maintenance program.
  • Review batch records and release product into finished goods inventory.
  • Conduct or participate in supplier audits as needed.
  • Assist with supplier management activities related to material non-conformances and audit findings.
  • Participate in FDA inspections, ISO certifications and surveillance audits and customer audits.
  • Support corporate Regulatory Affairs by providing information for submissions.
  • Identify and implement opportunities for continuous improvement.
  • Interact and coordinate activities with other departments, external vendors and customers.
  • As required, assist with the prompt implementation of non-Conformance resolution, complaint investigation, Corrective and Preventative Actions(s), and field actions.
  • Perform other Quality Systems related duties as required.

Qualifications

  • Bachelor’s degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (biology).
  • Minimum 5 years’ experience in a Quality Assurance role for medical device, pharmaceutical manufacturing or similar regulated environment.
  • Demonstrate the ability to identify appropriate tests and test methods, apply appropriate statistical sampling plans and other engineering calculations, and understand the application of risk management used in medical device manufacturing to support regulatory submissions and company compliance.

Preferred

  • Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc.
  • Demonstrates excellent organizational and communication skills and proficiency with the MS Office Suite.
  • Must be able to work both independently and in a team environment with minimal supervision.
  • Able to prioritize projects to meet organizational goals and objectives.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.