Quality Analyst at American Orthodontics Corp in Sheboygan, Wisconsin

Job Description:

Job Summary:

Support functions relating to Quality and Regulatory Affairs.  Lead activities to obtain and maintain product registrations (domestic and international).  Prepare regulatory documents.  Support Engineering changes.

Duties & Responsibilities:

• Lead and support product registration for both domestic and international customers
  
  
  
  • Coordinate efforts associated with the preparation of regulatory documents and submissions
  
  
  • Coordinate and prepare regulatory submissions for domestic and international projects
  
  
  • Prepare additional information or responses as requested by regulatory agencies
  
  
  • Communicate with customer service, and international customers 
  
  


• Prepare and maintain technical documentation


• Support Engineering and PDS teams
  
  
  
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards
  
  
  • Communicate with regulatory agencies
  
  


• Participate in internal and external audits


• Perform additional responsibilities as requested to achieve business objectives

Qualifications:

• High school diploma or equivalent required;  Associate or Bachelor's Degree desired


• Experience working in a regulated industry desired


• Demonstrated strong internal structure to successfully lead multiple activities simultaneously


• Demonstrated accuracy and thoroughness


• Ability to interpret regulations and apply the regulations to the organization


• Proficient with the Microsoft Office Suite, especially Excel


• Strong written and verbal communication skills required

See job description