Design Quality Engineer

This job has now expired please search on the home page to find live IT Jobs.

Design Quality Engineer

Ripon

£45000 + Hybrid work + Pension + holiday

Do you have experience of executing design control activities within a life science or medical device industry?

Are you interested in working in a new role where you would be able to stamp your mark on this company?

In this role you will provide Design Quality input and support various projects focusing on design control, risk management, usability, and general Regulatory Compliance support.

You will also lead the design control, risk management, and usability activities. This will incorporate Post Market monitoring, Risk Management, Design Control Plan elements, and coordinating qualification & validation processes as required.

The ideal candidate will have experience in the life science or medical device industry and have been working on a role where you have been executing design control activities this covers NPD and retrospectively correct design files.

This company are based in Ripon but they have a hybrid working system enabling people to come from further afield if needed.

This is a brilliant role for an engineer to join a rapidly expanding company where you can play a key part in this companies growth and development.

The role:

*Establish Design Control requirements ensuring compliance to all applicable standards.

*Creating retrospective Design History Files for legacy and acquired products.

*Deliver design transfer activities as part of New Product Development, ensuring transferred systems are understood and coordinated into the Quality System.

*Risk Management oversight, input, and review during DHF development and product life cycle phases in accordance with ISO14971.

*Creating retrospective Risk Management Files for legacy and acquired products.

*Driving the creation of or changes to appropriate Risk Management maintaining this plan to all phases of the product's lifecycle.

The person:

*Must come from a medical device or Life science background

*Experience of executing design control activities- NPD and retrospectively correct design files.

*Knowledge of FDA, ISO, and other specific Quality System requirements specific to Medical Device.

*Experience of interacting with National Competent Authorities, Notified Bodies and local Ministries.

To apply for this role or to be considered for further roles, please click "Apply Now" or contact Chris Dudbridge at Rise Technical Recruitment.

Rise Technical Recruitment Ltd acts an employment agency for permanent roles and an employment business for temporary roles.

The salary advertised is the bracket available for this position. The actual salary paid will be dependent on your level of experience, qualifications and skill set. We are an equal opportunities employer and welcome applications from all suitable candidates.