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Quality Specialist - Medical Device

  1. Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
31-08-2023
31367WP
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QA Specialist - 12 months - Med Device /Combination Device

QA Specialist required for a leading Pharmaceutical client based in Dublin. You will be required to provide a quality oversight  for the clinical and commercial combination products, from introduction throughout the product and design control lifecycle and the associated Quality System. 

You will be working with all stakeholders involved with product quality and design control risks through early detection and mitigation during product development and technology transfer.


You will be responsible for:
  • Support the development of the Design Development Plan in line with 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
  • 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.
  • Ability to work cross functionally with Development, Tech Ops, Regulatory Affairs, Quality Assurance.
Skills and experience required:
  • 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
Advantageous experience:
  • Experience in pharmaceuticals and combination product and device delivery systems.
  • Knowledge of process development and quality systems with a strong business and technical acumen would be an advantage.

Are you interested in this role? Apply today! 


The candidate must have the rights to work in the location stated in the job advert.

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