Integra LifeSciences

Rotational Associate, Quality, Regulatory & Global Operations

Vacancy ID
2017-24280
US-NJ-Plainsboro
Position Type
Regular Full-Time
Category
Regulatory Affairs

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."

Responsibilities

Our Quality, Regulatory, and Global Operations Rotational Development Program is designed to help you start a rewarding career in the medical device industry.   Our program allows for bright, talented individuals to develop through high-quality work assignments, mentoring from senior functional and business leaders, and training and certification opportunities. 

 

Our program offers a unique opportunity to fast track learning experiences specific to the high demand functional areas of Quality Assurance, Regulatory Affairs, and Global Operations. During this twenty-four-month program, associates will rotate through an eight-month assignment in the following functional areas at our corporate headquarters located in Plainsboro, NJ.

 

Quality Assurance:

 

During your Quality Assurance assignment, you will be dedicated to guaranteeing that our products are safe and effective for patient use. Your principal tasks involve monitoring our Quality Assurance programs and policies to ensure the development, manufacturing and distribution of medical device products are in compliance with all appropriate regulations and standards. Responsibilities include:

  • Ensure divisional and site Quality Management Systems are established, implemented and maintain their effectiveness in accordance with applicable standards.
  • Create, write and coordinate efforts for the development and implementation of new and updated Quality Systems procedures for FDA Quality System Regulations and ISO Regulations
  • Provide support for the preparation and execution of FDA inspections, ISO Audits and customer audits.
  • Tracking Quality System audits and their corrective actions for Integra facilities, both domestic and internationally as appropriate and assigned.
  • Ensure all projects and validations are in compliance with current FDA Good Manufacturing Practices (GMPs), QSR and ISO requirements.
  • Risk Management lifecycle support for products during the product development process and at post market review; coordinate and execute Post Market Surveillance Programs.
  • Preparing and reviewing Standard Operating Procedures, as well as maintaining the required documentation for each SOPs
  • Other Quality Projects and Special Quality Projects assigned by the Manager of the Quality Rotation

Regulatory Affairs:

While in your Regulatory Affairs assignment you will be primarily involved with helping to get our life-changing devices to market through submissions to FDA and International approval process. The primary role of this department is to ensure we meet the ever-changing worldwide regulation requirements during every stage of product lifecycle. Responsibilities will include:

  • Supporting Regulatory Management in developing a partnership with operations, manufacturing, Quality Systems, engineering and development in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
  • Assist in the review of documentation, protocols and reports received and prepare additional written materials as needed.
  • Conduct data collection for submissions, Design Dossiers and International submissions.
  • Writes and updates department Standard Operating Procedures.
  • Provide regulatory input to ensure activities are in compliance with all appropriate regulations and standards.
  • Keeps appraised of new regulations, standards, policies and guidance issued by relevant regulatory authorities that may impact the company.
  • International Regulatory Affairs-Latin America Asia Pacific (LAPAC) There will be opportunity to have a rotation in LAPAC to work on developing Core Dossiers for submissions to key target countries in LAPAC. In this rotation there will be opportunities to visit Integra facilities outside of NJ.

Global Operations:

While in your Global Operations assignment you will directly participates in high-quality work assignments, receive mentoring from senior functional business leadership, and learning experiences specific to the following functional areas:

 

  • Manufacturing Engineering
  • Materials Management
  • Planning & Forecasting
  • Quality & Regulatory Systems
  • Front Line Supervision

 

Will perform all required duties in compliance with company policies and procedures, U.S. Food and Drug Administration regulations, ISO 9001 and 13485, the Canadian Medical Device Conformity Assessment System (CMDCAS), the Medical Device Directive, and other applicable regulatory agencies.

 

Manufacturing Engineering:

  • Gain knowledge in project planning, project management
  • Evaluate manufacturing processes assisting in identifying process improvements.
  • Research product or process non-conformances and initiate corrective actions.
  • Research and conduct corrective actions for the plant Corrective and Preventive Action (CAPA) system.
  • Follow Lean Manufacturing principles; participate on project teams with other internal department members, external vendors and customers.
  • Materials Management

  • Ensure project goals and target inventory levels are maintained through prioritization, expediting, and communication of potential delays or bottlenecks to management.
  • Responsible for all related systems transactions, reporting, and record keeping. Planning and Forecasting
  • Gain knowledge in creating a plan, capacity review and management, forecasting systems, product life-cycle and products.
  • Will work closely with corporate Planning, Operations, Customers, and affiliates to ensure that proper products are being produced.
  • Responsibilities will include reviewing monthly corporate forecast requirements against systems generated requirements and plans for system, work order, and production schedule update needs.
  • Will verify accuracy of purchase orders, invoices or other documents and will maintain records of received goods
  • Assist in determining the satisfactory and quality of shipments for acceptance or rejection.
  • Will perform cycle counts and physical inventories as directed.
  • Follow Lean Manufacturing principles; participate on project teams with other internal department members, external vendors and customers.

 

Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

  • Graduating undergraduate or graduate seniors majoring in Biomedical Engineering or life sciences, Mechanical, Chemical or Industrial Engineering (biology, chemistry, etc.)
  • Minimum GPA of 3.2
  • Strong analytical and organizational skills
  • Excellent written and oral communication skills
  • Strong computer skills

  • Ambition for a career in the medical device industry

  • Previous internship and/or leadership experience preferred

  • Bilingual skills (English/Spanish) a plus

  • Willing to travel and potentially work outside of NJ for an extended period of time.

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