QA/RA Project Engineer

Our client, a global diagnostics company, are currently recruiting for a QA/RA Project Engineer.  This is a full-time permanent role reporting to the Head of QA/RA Projects.

 Purpose of job

To provide QARA support for all on-going and new projects.

Responsibility for Risk Management and Usability Engineering for new product introductions, and on-going maintenance of these files throughout the entire product lifecycle.  

Essential responsibilities

·      Support new project’s introductions to the Bray site by providing Quality, Risk and Usability expertise.

·      Review and approval of Design Verification and Design Validation documentation.

·      Initiate Risk Management and Usability activities for new projects.

·      Ongoing maintenance of Risk Management Files and Usability Engineering Files.

·      Work constructively with team members from R&D, Marketing, Operations, Quality Assurance, Technical Support, Clinical Affairs, Customer Service, and Finance, and the wider Group.

·      Assist in ensuring that product Technical Files and Design History Files comply with requirements and are kept up to date.

·      Support the product registration and regulatory submissions processes where required.

Qualifications

• An advanced life science degree with experience in medical devices or biological sciences

·      2-5 years + experience of which at least 1-2 years’ industrial experience in a QARA role in the Medical Device or similar industry, preferably in IVDs

• Knowledge of FDA QSR, 21CFR820, ISO 13485, HC Medical Device regulations, ISO 14971, IVD Regulation 2017/746/EU
• Quality Auditor qualification desirable
• Demonstrated competence in biochemical techniques and statistical concepts. 

·      Experience in the field of Haemostasis/ IVD industrial experience would be advantageous.

Skills and Behaviours

• Team player – ready, willing and able to take direction and receive constructive feedback
• Ability to read, analyze, and interpret technical data, and technical procedures
• Ability to research a subject/process to a deep level of understanding and summarise into a coherent form for discussion and review, and to suggest ways forward
• Self-motivated with strong work ethic and ability to prioritize

·      Ability to effectively present information and respond to questions from groups of managers, clients, and customers.

Language Skills

Fluent English both written and oral.

For full details contact Tina or Linda at +353 1 2784701 or email your CV to tdunne@thornshaw.com

Thornshaw Scientific is a leading recruitment partner and a division of the CPL Group www.thornshaw.com

Published URL

Website Job URLWebsite Job URL

https://www.cpl.com/job/qa-slash-ra-project-engineer-3

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Tina Dunne

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