AZNJP00028329-QA Specialist – Medical Device-Dublin Contractor

This is a 12 month contract.

Purpose

The Medical Device QA Specialist is to provide QMS support for combination products for the product lifecycle and the associated Quality System. The successful candidate will proactively engage with all stakeholders involved with product quality. The QA 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.

Requirements

• Minimum of a bachelors 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.