QA Specialist, Combination Products
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2399 |
| Job Views | 112 |
- Description
- We are seeking applications for a QA Specialist for Combination Products for our client who are a leading Biotech company based in Dublin.
In this role you will provide quality oversight and support for clinical and commercial combination products for the product lifecycle and the associated Quality System. As a significant quality contributor, you will proactively engage with all stakeholders involved with product quality during technology transfer and post market support. You will be 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 decision making related to the quality and design transfer of our combination products.
Why you should apply:
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:
Responsible for maintaining a compliant Quality System for combination products that supports weekly/monthly QMS governance reporting.
Responsible for collection of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meeting, minutes and actions.
Support process improvements by gap analysis of existing SOPs or processes against medical device standards and regulations and making updates accordingly.
Supporting Periodic Review and working cross functionally to ensure stakeholder feedback is included in any document updates.
Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system
Partner with Quality Scaled Digital Services (QSDS) to ensure successful deployment of a combination product Quality Management System.
Support cross functional teams with Supplier Change Notifications and Supplier Quality Agreements updates.
Facilitates global and local changes with respect to combination products and risk management files.
Ensure timely entry, processing, and closure of quality records in compliance with procedures.
Liaise with third parties such as device constituent partner manufacturers related to device related investigation outcomes and root cause assessments.
Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
Supports Notified Body and Health Authority inspections and compliance.
Communicate effectively, both verbally and in writing, internally across departments and with external partners.
Comply with the quality assurance requirements as well as applicable regulatory requirements.
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.
