QA RA Project Engineer

On behalf of our client, a global diagnostics company, we are currently recruiting for a QA RA Project Engineer.

This role reports to Head of QARA Projects

Purpose of job

To provide QARA support for all on-going and new projects. Specifically projects related to assay development and instrument projects, including software but also to include change management projects and improvements to ensure projects are delivered on time and conform to applicable Quality and Regulatory requirements. 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

• 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.

For full details contact Linda at +353 1 2784701 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com