Quality Assurance Analyst

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Job description

Supporting the QA, Design, & Development functions across new-to-market IVD products

Your new company
My client is a scale-up business specialising in medical devices and aiming to be the next household name within IVDs. Progressing from internal research to public marketing, this is the most exciting time to join them. Reporting to the QA \/ RA Executive, you'll be working closely with the QA team in managing all documentation within the eQMS. This role will give you the opportunity to provide input on the design and quality standard of the new product.

Your new role

* Partnering with the R&D team to deliver new products to market;
* Guiding all relevant teams through consistent and compliant delivery according to Design Control and Risk Management processes;
* Supporting development of plans, test methods and reports required for the Design History Files
* Supporting CAPA investigations and administration;
* Working as part of the quality team in implementing and performing post market surveillance activities;
* Facilitating and maintaining employee training records within the company's eQMS;
* Playing a vital role in audits by notified bodies and competent authorities.

What you'll need to succeed

* Experience in consumer IVDs and\/or medical devices;
* eQMS development and the ability to interpret regulations;
* Good knowledge of IVDD, IVDR, ISO 13485, and 21 CFR 820;
* Experience in complying with laboratory health, laboratory protocols and safety regulations;
* Experience with documentation control and preparing quality documentation and reports;
* Experience in processing customer returns compliant to ISO 13485.

What you'll get in return

* 30 days annual leave plus bank holidays;
* \u00A3200 annual personal development allowance + unlimited access to Sunlight Learning & Development platform & content;
* Cycle Scheme, City Bike to Hire Scheme & Tech Scheme via salary sacrifice;
* Regular company socials;
* On-site gym.

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 contact Sandy Vo on .
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.