TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Rotation Associate.US-HDQ.002

Company: Integra LifeSciences Holdings Corporation
Location: Princeton
Posted on: June 10, 2021

Job Description:

Overview

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.

Responsibilities

Quality Assurance:

During your Quality Assurance assignment, you will be dedicated to assuring 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 will 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), Quality System Regulations (QMR) 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 (SOPs), 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 Regulatory agencies. 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 product development in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
  • Attend a 510(k) Premarket Notification Training Program.
  • Assist in the preparation of 510(k) Premarket Notification submissions to FDA.
  • Assist in the review of documentation, protocols and reports received and prepare additional written materials as needed.
  • Conduct data collection for submissions, Design Dossiers, Technical Files 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.

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

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 lifecycle 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.

Special Projects - there are opportunities for Special Projects as defined by the senior level management in Regulatory Affairs, Quality Assurance, and Operations. These special projects can involve travel in the US..

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

Keywords: Integra LifeSciences Holdings Corporation, Trenton , Rotation Associate.US-HDQ.002, Other , Princeton, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds