DUTIES AND RESPONSIBILITIES (essential functions of position):

• Nothing in this job description restricts managementâ??s right to assign or reassign duties and responsibilities to this job at any time.
  
• Provide overall direction to the following functions: Customer Complaints, Internal Audits, CAPA, Document Control, Quality Engineering, Supplier Quality and Employee Training.
  
• Drive continuous improvement and optimization of the Quality Management System and supporting processes.
  
• Ensure new/emerging regulatory requirements are identified and effectively incorporated into the Quality Management System.
  
• Interface with ISO Registrar, Authorized Representative and government agencies, as necessary.
  
• Oversee the development of the department staff and infrastructure.
  
• Develop and manage the department budget.
  
• Regular attendance required.
  

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:

• 5 or more years experience as a Quality Systems Director or Manager.
  
• Full understanding of U.S. FDA a??s Quality System Regulations (21 CFR 820), ISO 13485 and ISO 14971 requirements.
  
• U.S. FDA establishment inspection experience.
  
• 4 year degree or higher required.
  

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):N/A

SUPERVISORY RESPONSIBILITIES:

• Supervise the Quality Assurance Department.
  
• Develop and manage department staff and budget.
  

PHYSICAL DEMANDS AND WORK CONDITIONS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.