Job Description

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.

Provides Quality Assurance support to an assigned area. Non-supervisory, provides advice in areas of processes and procedures. Role holder ensures efficient processes and procedures are maintained within the boundaries of regulatory compliance for relevant GxP.

Key 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.


Requirements