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Quality Systems Manager - United States  

DiaSorin (company)


Posted on : 04 July 2017

Project Description

Job Scope
Your Mission  
To ensure compliance to FDA ISO, and various regulatory requirements through management of Document Control, Product Release, Internal audits, and CAPA systems.  Supports applicable regulations including International, Local, State, and/or Federal requirements.    

Main Responsibilities
 Your Contributions   
  • Ensure the facility is in compliance to ISO13485, IVDD, CMDCAS, and QSR requirements. 
  • Provides a leadership role in the effort to promote continuous improvement of Quality System processes. 
  • Develops, monitor and meet, department and individual goals & objectives. 
  • Creating a sense of urgency and helping team to deliver projects and activities to agreed upon deadlines. 
  • Manage the manpower, equipment and resources for effective operations. 
  • Oversee the internal quality audit system. 
  • Oversee the CAPA system as it relates to universal issues. 
  • Oversee the document control system. 
  • Oversees the training system 
  • Oversee the product release process 
  • Generate key performance indicators and Support Management  
  • Review process.  
  • Follow corporate policies and procedures. 
  • Participates/supports in the audits of third party audits. 
  • Supervises Employees.     

Bachelor’s Degree   
Specialization  N/A   

  • Requires 4 or more years working experience in the healthcare industry.   
  • Requires supervisory experience. Other relevant experience may be considered.     

Technical Competencies   
  • ASQ Certified Auditor a plus. 
  • Working knowledge of Industry related Quality Systems, Medical Device QSRs, familiarity with International Quality Standards.     

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.   
  • Ability to write reports, business correspondences, and procedure manuals.   
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.   
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis. 
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.   
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.     

Languages  Fluent spoken and written English   
Travel Availability  Not required   
Relocation Availability  Not required   
Training Required  Not required