Quality Systems Specialist

https://www.teamhorizon.ie/job-search/1316-quality-systems-specialist/quality/dublin/job2024-04-24 16:08:362051-09-08Team Horizon
Job TypeContractor
AreaDublin, IrelandDublinIreland
SectorQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3276
Job Views740
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 820 QSR, ISO 13485:2016, 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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