Quality Specialist for Medical Device Combination Products
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2925 |
| Job Views | 1249 |
- Description
- Team Horizon is seeking a Quality Specialist for Medical Device Combination Products. This role is based at our client’s manufacturing facility in Northwest Dublin. In this role you will be a key member of the member of the Global Quality team and be 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.
Why you should apply:
Work with a company who are passionate about improving the health and the lives of their patients worldwide through the development of treatments and products to treat a range of therapeutic areas.
Opportunity to be part of a progressive & dynamic team with flexible hybrid working options.
What you will be doing:
Support the development of the Design Development Plan in line with applicable regulations for combination products including Planning, Design and Development, Design Verification, Design Validation, Technology Transfer and Risk Management
Responsible for ensuring quality compliance during design transfer from development to manufacturing.
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.
Provide Quality Engineering input on developing CTQ criteria and specifications for Combination product raw materials, in-process and finished product acceptance activities as required
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.
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.
Partner with Quality Scaled Digital Services (QSDS) to ensure successful deployment of a combination product Quality Management System.
Support risk assessments relating to batch release or 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, Regulatory Affairs, Quality Assurance.
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.
Other duties as assigned.
What you need to apply:
B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry.
Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
4 years +’ cGMP experience within quality in a medical device, combination product R&D or manufacturing environment, ideally clinical phases through commercial understanding of medical device development for the full lifecycle starting at the Design Control phases.
Demonstrated ability in decision making, problem solving and project management.
Excellent communication and interpersonal skills
