QA Specialist (Medical Devices)
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| Job Type | Contractor |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2227 |
| Job Views | 374 |
- Description
- If you are experienced in Medical Device Quality Assurance, we have an exciting opportunity available with our client a globally recognised company who are based in Dublin.
In this role you will provide quality oversight and support for clinical and commercial combination products from introduction throughout the product and design control lifecycle and the associated Quality System.
As Medical Device Combination Product Specialist, 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 regulatory compliance with design control activities and documentation, technology transfer to manufacturing and QC testing processes. The role enables efficient communication and decision making related to the quality and design control of our combination products.
The position reports into the Quality Medical Device Combination Product Lead and is a member of the Medical Device Quality Team.
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:
Responsible for maintaining device CMO Quality Assurance
Liaise with CMO for device complaints, investigations and root cause assessments.
Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
Support the development of the design control quality plan in line with applicable regulations for combination products including Planning, Design and Development, Verification, Validation, Technology Transfer and Risk Management.
Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management and supporting operational procedures.
Facilitates global and local changes with respect to the product and design control
Ensure timely entry, processing, and closure of quality records in compliance with company procedures.
Support risk assessments relating to product quality for clinical and commercial products.
Supports Notified Body and Health Authority inspections and compliance.
Ability to work cross functionally with Development, Tech Ops, Quality Assurance.
Communicate effectively, both verbally and in writing, internally across departments and with external partners.
Comply with the company 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.
Risk Management Standard for Medical Devices ISO 14971 2019
