• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs

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 three, eight-month assignments in the following functional areas at either our corporate headquarters located in Princeton, NJ, or other Integra site.

SUPERVISION RECEIVED

Under the direct supervisor of the Corporate VP of Operations. Rotational Associates will also receive supervision under direct supervision of the Manager of each Rotation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

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.

• 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.
• Prepare and review Standard Operating Procedures (SOPs), as well as maintain the required documentation for each SOP.
• Other Quality Projects and Special Quality Projects assigned by the Manager of the Quality Rotation.

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:

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:

• Support 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.
• Write and update department Standard Operating Procedures.
• Provide regulatory input to ensure activities are in-compliance with all appropriate regulations and standards.
• Keep appraised of new regulations, standards, policies and guidance documents issued by relevant regulatory authorities that may impact the company.

Global Operations:

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

• Gain knowledge in project planning and project management.
• Evaluate manufacturing processes and assist 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.

• 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.

• 
  Gain knowledge in creating a plan, capacity review and management, forecasting systems, product lifecycle and products.
• Work closely with corporate Planning, Operations, Customers, and affiliates to ensure that proper products are being produced.
• Reviewing monthly corporate forecast requirements against systems generated requirements and plans for system, work order, and production schedule update needs.
• Verify accuracy of purchase orders, invoices or other documents and maintain records of received goods.
• Assist in determining the satisfactory and quality of shipments for acceptance or rejection.
• 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.

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