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Quality Systems Specialist

Quality Systems Specialist

TEAM HORIZONDublin, Ireland, IE
30+ days ago
Job description

Description

Team Horizon is seeking a Quality Systems Specialist for our client, a leading Biotechnology company in Dublin. This is a 12-month initial contract.

Why you should apply :

  • Exciting opportunity to provide QMS support for combination products for the product lifecycle and the associated Quality System and engage with all stakeholders involved with product quality.
  • Flexible working
  • Competetive salary / rates

What you will be doing :

  • Supports weekly / monthly / quarterly QMS governance reporting.
  • Responsible for collection of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.
  • Partner with Central Quality Systems and Compliance (CQSC) to ensure successful deployment of a combination product Quality Management System.
  • Support cross functional teams with review board meetings (e.g. Change control, Supplier Change, change planning, Standards review planning) and Supplier Quality Agreement updates
  • Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
  • Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system
  • Ensure timely entry, processing, and closure of quality records in compliance with procedures.
  • Supports Notified Body and Health Authority inspections and compliance.
  • Supports Combination Product Audit readiness initiatives.
  • Supporting Periodic Review and working cross functionally to ensure stakeholder feedback is included in any document updates.
  • Support process improvements by gap analysis of existing SOPs or processes against medical device standards and regulations and making updates accordingly.
  • Communicate effectively, both verbally and in writing, internally across departments and with external partners.
  • Comply with the company quality assurance requirements as well as applicable regulatory requirements.
  • Other duties as assigned.

    • What you need to apply :

  • Minimum of a bachelor’s degree in biological / chemical sciences, biomedical / mechanical engineering, or other related subject.
  • Minimum of 4+ years’ experience in Quality in a regulated environment.
  • Knowledge of the regulatory and compliance requirements of FDA 21 CFR Part QSR, ISO : , EU MDR.
  • Familiarity with SAP, Veeva Vault and Trackwise would be desirable.
  • Excellent communication & presentation skills.
  • An ability to work independently, as well as a member of a team in a dynamic, fast – paced environment.
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    Quality Specialist • Dublin, Ireland, IE