Quality Assurance NPI

We are recruiting for a QA NPI for a medical device company in Ballymena.

Your new company
A medical device manufacturer in Ballymena who are thriving in the current market. All tests and equipment in the business are manufactured to the highest standards and are supplied across Europe.

Your new role
Due to new growth the company have a requirement for a full-time QA NPI Specialist with experience in the Medical and In Vitro Diagnostic Device areas.
You will work closely within the new product introduction, NPI, group to bring new products to the market on a worldwide basis, liaise with new and existing suppliers and sub-contract manufacturers regarding potential new products and their technical, performance, QMS and compliance claims. Review suppliers for inclusion on the approved vendor list, define, create, and maintain design level files for new and existing products. You will review, assess and test potential new products, review technical documentation and labelling for compliance with quality and regulatory requirements, work with the regulatory department to generate and maintain technical files, maintain related QA files, databases, and chronologies in good order to track changes in documents per document and change control procedures. You will work with managers and staff to develop and execute company, technical and QA strategies to meet and exceed customer and company goals.
You will be an integral member of the QA group

What you'll need to succeed
Ideally you will have a degree in Engineering or Biological discipline or Other Relevant Science ( new graduates accepted) or equivalent work experience. Relevant experience in a design, quality and/or manufacturing technical role obtained in a Medical Device or In Vitro Diagnostic Device environment or similar environment. You will be proficient with MS office suite of products. Candidates who have exposure to a NPI process for MD and/or IVD’s would also be desirable as well as exposure to other worldwide regulatory systems, e.g., FDA, Canada Health, TGA etc, exposure to performance and technical documentation for MD & IVD’s and current working knowledge of ISO 14971, and ISO 13485:2016 as well as European regulations for Medical and In Vitro Diagnostic devices.

What you'll get in return
Competitive salary in an innovative medical device company.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #4261505
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Job Type
Working Pattern

Talk to a consultant

Talk to Lisa McCord, the specialist consultant managing this position, located in Portadown
1st Floor, Unit 11c, McGowan West Shopping Centre, West Street

Telephone: 003330103917