Quality Assurance Specialist
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002706 |
| Job Views | 5 |
- Description
- Team Horizon is seeking a Quality Assurance Specialist (initial 12-month contract) for our client, who are a leading biopharmaceutical company. 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.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
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. 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 client’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 client’s quality assurance requirements as well as applicable regulatory requirements.
Other duties as assigned.
What you need to apply:
Minimum of a B.Sc. degree in biological /chemical sciences, biomedical/mechanical engineering, or other 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.
