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Quality Systems Manager

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 26/04/2018
  • Job reference: J382786A

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Quality Systems Manager

My client, a world leading medical device organisation, is currently looking for a Quality Systems Manager to join their team. In this position, you will be tasked to set up, maintain and improve the legal manufacturers QMS and to participate in the delivery of QMS changes for MDR implementation

  • Participate in the implementation of MDR for sites which includes performing gap assessment for MDD, ISO and MDR, identifying and remediating gaps in the QMS
  • Liaise with cross functional teams on the project, communicating with stakeholders, project management of the QMS changes
  • Change management activities for the implementation of MDR QMS requirements
  • Set up, maintenance and continuous improvement of the legal manufacturer's quality management system for multiple sites follows current Medical Device Directives, ISO 13485 and applicable global regulations & standards for all identified products.
  • Perform activities required to maintain an agile, efficient quality system including developing & reporting relevant metrics to the global business unit leader for all applicable sites under the Legal manufacturer's responsibility as well as the generation and maintenance of relevant Quality Performance Metrics.

RESPONSIBILITIES

  • Direct the multi-disciplinary activities required to ensure that the requirements of the MDR project and the legal manufacturer responsibilities are adequately defined within the quality management system including but not limited to the generation of Quality agreements with various functions & outsourced processes.
  • Generation & update of relevant procedures to comply with changing standards & regulations within the business unit.
  • Responsible for updating the QMS for the legal manufacturer & business unit QMS to comply with existing & emerging quality regulations & standards
  • Responsible for working with functions, outsourced processes & manufacturing to determine the legal manufacturer architecture, associated documentation and associated governance
  • Lead the legal manufacturer audits with relevant authorities & internal compliance group

QUALIFICATIONS

  • Degree in a quality, scientific or engineering discipline with a minimum of 5 years related work experience in the Medical Device industry with a thorough knowledge of Quality Systems, Quality Assurance, and regulatory requirements.
  • Excellent report writing and documentation skills.
  • Specific knowledge of legal manufacturer requirements as defined by EU legislation is necessary
  • Broad regulatory and standards knowledge in the medical device sector.
  • Dealing with multiple functions & areas to develop/ updates


For more information on this or similar position, please contact Kathryn on 016455244 or email