Global Quality Specialist

Team Horizon is seeking a Global Quality Specialist for an initial 12-month contract with a Client in Dublin.

Why you should apply:

• Join a team who unleash bold thinking with the power to inspire life-changing medicines.


• Hybrid role with a mix of in-person working to give a platform to connect, work at pace and challenge perceptions with balance of remote working 2 days per week.

What you will be doing:

• Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.


• Supports Combination Product Audit readiness initiatives and support during audits.


• Supports Notified Body and Health Authority inspections and compliance.


• Responsible for collection/collation of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.


• Supporting weekly/monthly/quarterly QMS governance reporting.


• Support cross functional teams with review board meetings (e.g. Change control, Supplier Change, change planning, Standards review planning, risk review) and Supplier Quality Agreement updates. Supporting action includes coordination of review meetings including documenting minutes & actions and filing of records.


• Ensure timely entry, processing, and closure of quality records in compliance with procedures.


• Attending site team meetings relating to operations activity to ensure quality compliance for combination products.


• Support Deviation / CAPA processes by providing oversight of content for compliance, supporting owners in initiating CAPAs and completing action tasks per SOPs to completion on time.


• Support change control initiators to ensure change control documentation meets combination product  regulations per SOPs.


• Ensure change control documentation including impact assessments are ready and adequate for approval at Change Control Review Board.


• Liaise with third parties such as device constituent partner manufacturers related to device related investigation outcomes and root cause assessments.


• Partner with Quality partners to maintain and improve the  combination product Quality Management System.


• Communicate effectively, both verbally and in writing, internally across departments and with external partners.


• Comply with the quality assurance requirements as well as applicable regulatory requirements.


• Other duties as assigned.

What you need to apply:

• Minimum of a bachelor’s degree or equivalent experience in a regulated industry.


• Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g. FDA QMSR 21 CFR Part 820 and Part 4 / ISO 13485 and Regulation (EU) 2017/745), ISO 14971.


• Experience using electronic QMS / document management systems (e.g., Veeva Vault) for document lifecycle, quality events, and action tracking.


• Demonstrated experience managing quality or compliance- related projects in a regulated medical device and/or combination product environment. 


• Proven ability to plan, track, and deliver projects while maintaining focus on compliance, quality, and timelines.


•  Experience applying a structured, risk based approach to continuous improvement within a Quality Management System.


• Excellent communication and interpersonal skills


• Knowledge of quality systems with a strong technical acumen would be an advantage.


• Preferable 4 years +’ cGMP experience within quality in a medical device, combination product R&D or manufacturing environment.