Quality Manager I

Cambridge, MA

Posted: 07/31/2019 Industry: Biotech/R&D/Science Job Number: 49332

Duties: 

The primary role will be to manage QA elements of cGMP Quality System at the Cambridge facility.  

As a member of the Cambridge Quality team, the person will work closely with Software Development personnel and the Frankfurt Quality team in support of medical device development activities.  

Essential job junctions with respect to the Cambridge facility  include: 
  • Managing  the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant  manner 
    • Ensuring  the effectiveness of the CAPA program at the  site 
  • Managing  the Event portfolio to ensure Event closure in a timely and compliant  manner 
  • Leading  or supporting root cause  investigations 
  • Managing  the Cambridge Training  Program 
  • Providing  support of site  audits 
  • Participating  in the creation and updating of processes and work  instructions 
  • Daily  QA activities and related cGMP  compliance 
  • Knowledge  of FDA Regulations Part 11 and Part 820, ISO 13485, and IEC 62304  

Skills: 
  • Experience in medical device, pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.  
  • Ability to work on strict deadlines.  Ability to interface with cross-functional teams. Detail oriented.  
  • Working knowledge of the FDA Quality System Regulation.  
  • Experience leading CAPA (Corrective and Preventive Action) activities.  
  • Well-developed communication skills, both verbal and written.  
  • Understanding of software engineering and development and experience in a relevant department has software as part of a medical device is a plus. 

Education: 

  • Bachelor' s  degree in engineering or technical discipline 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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