Quality Systems Specialist

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.