Quality Systems Analyst - Audits & Metrics
Plainsboro, NJ

Job Description

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

The Quality Systems Analyst, Audits and Metrics directly supports the governance activities such as assessments and revisions associated with compliantly maintaining Integra's Global Quality Management System. The individual must possess the ability to establish and maintain effective working relationships with Integra QA, RA and Operations Team members worldwide.

* Maintain current knowledge of FDA and any other applicable international Quality System regulations for medical devices and human tissue products.
* Conduct and participate in quality system audits that monitor the level of Integra site compliance to applicable Quality System regulations and Integra standards.
* Tracking Quality System audits and their corrective actions for Integra facilities, both domestic and internationally as appropriate and assigned.
* Develop, collect, and analyze corporate Quality System Metrics and report out to key internal customers.
* Develop, maintain and apply monitoring tools as applicable to effectively assess and ensure adherence to corporate polices and regulatory requirements.
* Maintain individual and departmental metrics. Prepare, organize and summarize reports for department and corporate management use.
* Provide and / or contribute to innovative solutions to meet the changing regulatory compliance environment and compliance goals while minimizing complexity of implementation for Integra organizations.

Qualifications

* Bachelor's Degree in Life Sciences minimum; advanced degree preferred
* Regulatory Affairs Certified (RAC)
* Quality System Auditor (RABQSA, AQS, etc.) preferred
* 3-5 years within an FDA regulated industry in a compliance role minimum; 5-8 years preferred.
* Computer skills to include knowledge and experience using Microsoft Office (or equivalent, SharePoint and proficient use of contact sources for regulations and compliance on the worldwide web network.
* Strong analytical and organizational skills
* Experience synchronizing data and preparing presentations for senior leaders
* Excellent written and oral communication skills