Quality System Specialist

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On behalf of our client, a multinational medical devices company, we're looking for a 

Quality System Specialist

Main duties:

Quality Systems Complaints / CAPA / NCRs

  • Manage the recording, investigation and resolution of product complaints, product problems, or safety issues
  • Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation
  • Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting
  • Generate KPI data around Complaint, CAPA, NCR and continuous improvement

Validation support

  • Provide support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates
  • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team

Environmental and testing

  • Co-ordinate the environmental monitoring activities of the contractors
  • Manage in process bioburden / Microbial ID monitoring
  • Ensure all environmental metrics are maintained up to date

Regulatory Affairs Support

  • Provide support with all international country submissions
  • Provide support to solve and reply to any regulatory query
  • Help to manage and maintain all documentation including Technical Master File

Operational Support

  • Support the preparation of change notifications/Validation protocols and Reports
  • Support sterilisation validation / revalidisation
  • Provide ongoing manufacture support to help the team meet its business objectives
  • Provide Quality role in new product introduction and transfers to production
  • Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs

Main requirements:

  • Experience in working in High Volume Production Facility
  • Strong computer skills - Change control management; design, process and system.
  • Familiarity with ISO quality systems ( ISO13485 – 21 CFR 820)
  • Good customer relation skills
  • Ability to present an independent opinion
  • Good communication and interpersonal skills -communicate highly technical information, both verbally and in writing, to both non-technical and technical associates
  • Quality of work / Attention to detail; maintains high standards despite pressing deadlines
  • Problem Solving (using recognised tools) and decision making (makes sound factual decisions)
  • Risk Management including FMEA generation

What is offered:

  • Competitive salary
  • Job location in Ireland 
  • Working in an international environment 
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