Senior Director, Quality Assurance North America

We are a global bio-technical organization dedicated to supporting healthcare providers with a broad range of medical solutions.  We are currently seeking a Sr. Director, Quality Assurance North America for our North Carolina location.  The Sr. Director will ensure the Quality System is built around contemporary principles of Total Quality and deploy the company?s Quality System processes and procedures throughout the medical and surgical facilities in North America. 

 

Responsibilities include:

  Ensure the Quality System meets all relevant medical device regulatory   requirements.  Ensure that the organization understands, embraces, and employs sound quality methodologies and regulatory requirements.  Maintain and report on a set of metrics that accurately, timely, and cost effectively measure and communicate Quality performance. Ensure that corrective and preventive actions taken are thorough and appropriate in response to internal audit findings and regulatory body inspections. Ensure that the medical and surgical manufacturing sites participate,  develop and  execute annual quality plan for the company.   Monitors the regulatory environment in North America and translates changing regulatory requirements into Quality policies and processes  Provides strategic and tactical direction to staff and others engaged in the auditing, quality planning and quality systems development and deployment   activities. Counsel with Quality Managers, Plant Managers and/or Vice Presidents and GM?s in the annual process of goal setting  Responsible for operating & project expenses, staffing & development activities  

 

Education

BS degree in technical or life science field

 

Work Experience

15+ years in the medical device industry, with at least 10 years in a Sr. Management position in the Quality function.  Expert in state, Federal and international regulations.

 

Please respond with job title in the subject line of your e-mail.  E-mail to:  confidentialjobopenings@yahoo.com