QA Manager required by multinational medical devices company in Offaly. In this role, you will be responsible for managing a QA team, will be the Plant Management Quality Representative and will be an effective part of the Site Management team.  

Key Responsibilities:

  • Assures quality products and processes, and Quality Standard Compliance 
  • Establishes and maintains a permanent improvement process of the QA Organization and of the Quality System
  • Ensures the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements
  • Management of QA staff, and be the Management Quality representative inside and outside the plant (Competent Authorities / Notified Bodies, etc)
  • Be an active and effective part of the Management team of the Site

 

Requirements: 

  • Degree in a Science based discipline
  • 15 years’ experience in a quality function in the medical device / pharmaceutical industries
  • Experience in a Quality Management role within the medical devices / pharmaceutical sector
  • Demonstrated knowledge of EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
  • Performance management
  • Strong project Management skills
  • Strong Leadership skills
  • Demonstrated planning excellence
  • Strong analytical skills, exceptional writing and interpersonal relationship skills
  • Excellent communication skills (verbal and written)

Desirable:

  • Master’s Degree in a scientific or engineering discipline
  • Experience in Process Excellence tools is highly desirable

Please contact Emer Moore to discuss in confidence

00353578638188       
emoore@emtechrecruitment.ie

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