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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality Systems Manager


Reference:JC2903 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed


Our client a high potential medical device start up are currently seeking a Quality Systems Manager to join their team. TheQuality Systems Manager, you will provide hands-on leadership to the rest of the organisation in terms of quality systems, knowledge, compliance and training.Successful candidate will provide strategic project direction and ensure that regulations, standards and requirements as implemented are up-to-date, identify compliance gaps and take action to address them.


Role/Responsibilities:

  • Manage the Company's electronic QMS System.
  • Maintain the Company’s training system.
  • Manage suppliers, including supplier selection, auditing, and qualityagreements.
  • Responsible for purchasing controls, including quotes, PO's, invoices, and payments.
  • Manage the document control system, including control of records.
  • Leading Management Reviews and Quarterly Review Meetings.
  • Documentation of internal audits.
  • Control of non-conforming and CAPA system.
  • Management and control of product complaint management system.
  • Responsible for post market surveillance systems.
  • Leading continuous improvement systems.
  • Pro-active lead on external audits (Regulatory Agency and Notified Body) and co-ordinate such activities as required.
  • Maintain Design History Files.
  • Performance of documentation reviews for design control documents and QMS documents in general.
  • Material contribution to the risk management process.
  • Co-ordination of design reviews.
  • Manage, support and co-ordinate with Regulatory Consultants and other Consultants to support the business needs.
  • Be a core member of the management team, feeding into the company's goals and business strategies.
  • Proactively drive a quality culture within the organisation.

Skills/Experience:
  • A Bachelor's degree in Engineering or Science related field.
  • Minimum 10 years of quality management experience or equivalent in the medical device industry and/or an FDA regulated environment.
  • Must have experience in people leadership.
  • Solid quality and systems background.
  • Demonstrated knowledge and application of Design Controls.
  • Excellent knowledge of Quality Assurance.
  • Exceptional leadership and technical competencies.
  • Excellent communication skills, including the ability to communicate to all levels of an organisation.
  • Good analytical and problem-solving skills.
  • Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance.
  • Strong leadership skills, including influencing and team development skills.
  • Thorough knowledge of QSR and ISO quality system requirements.
  • Good understanding of MDR 2017/745.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322