Retained Executive Search

Vice President Global Quality Systems
(New Jersey)

Fast growing global Medical Device organization, with a stellar industry reputation, seeks to add an Executive to its leadership team for a breakthrough career opportunity. In this highly visible role you will assist with their on-going expansion plans domestically and internationally.

In this role you will be responsible for setting the strategic direction and overall management of Quality Assurance and Regulatory Compliance programs for the Global Operations division of a leading medical device organization.  This position plays a leadership role in defining the Quality System strategy.

Description:

• Ensure that the division is in compliance with all national and international governmental quality system regulations.
• Manage and direct all staff and processes for quality systems globally as well as for all individual plants and facilities in the division.
• Maintain compliance with all applicable FDA Quality System Regulations, ISO 9001, and other applicable national and international guidelines.
• Direct the division’s objective strategic planning, direction and leadership for all Quality Assurance Programs and Processes.
• Demonstrate a proactive approach to Quality Systems.  Identify, review and anticipate emerging issues likely to impact the division and monitor this evolution.  Develop strategies for influencing the outcome of key issues and recommend appropriate actions to the other members of his management team.
• Strategic planning, direction and leadership for Quality System activities including research, registration, and compliance with governmental regulations for new device research and development, marketing and environmental matters.
• Develop, coordinate and implement documentation and maintain systems, procedures and documentation that will assure compliance and minimize negative regulatory actions in the areas of Quality System (GMP) and Good Laboratory Practice (GLP) compliance.
• Provide Executive Management with strategic Quality System evaluations of new acquisitions.

Requirements

• Bachelors or Masters Degree in Engineering or related scientific discipline - 5 + years of experience in Quality Assurance and/or Engineering in manufacturing positions in the medical device industry - TQM, Lean Manufacturing, and Six Sigma working knowledge preferred; experience as the lead liaison for FDA and ISO audits/inspections

Compensation

• Highly competitive salary, bonus and benefits with an excellent opportunity for career advancement.

To apply send your resume/CV to
submit@radiansearch.com or call (858) 863-0088 for details