QA Specialist QMS - Combinational Products

Barden are delighted to be supporting our Global Pharmaceutical client in their search for  Contract Quality Assurance Medical Device Combination Product Specialist for their state-of-the-art facility in Dublin.

ABOUT THE ROLE:

The Medical Device Combination Product Specialist is to provide quality support for clinical and commercial combination products for the product lifecycle and the associated Quality System. The successful candidate will proactively engage with all stakeholders involved with product quality during product development and post market support. The Medical Device Combination Product Specialist is a member of the Global Quality Organisation who is a quality liaison between Global Product Development (US Based), Manufacturing Operations, Quality Control, and Quality Assurance (US and Ireland) to ensure QMS and regulatory compliance. The role enables efficient communication and compliance for medical devices and combination products.

Responsibilities:

• 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. Supporting action includes coordination of review meetings including documenting minutes & actions and filing of records.
• 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 Alexion’s 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 Alexion’s quality assurance requirements as well as applicable regulatory requirements.
• Other duties as assigned.

ABOUT THE PERSON:

• Minimum of a B.Sc. degree in biological /chemical sciences, biomedical/mechanical engineering, or another related subject.
• Minimum of 4+ years’ experience in Quality with medical device or combination products in a regulated environment.
• Knowledge of the regulatory and compliance requirements of FDA 21 CFR Part 820 QSR and CFR Part 4, ISO 13485, EU MDR and Risk Management Standard for Medical Devices ISO 14971 2019.
• Familiarity with SAP 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.