Quality Engineer

Essex
£40,000 - £45,000 + bonus

Are you a Quality enthusiast with a passion for driving quality to the next level? Do you have a strong background in Medical Device manufacturing? We're on the hunt for a sharp, proactive Quality Engineer who thrives in a fast-paced, regulated environment. You'll be at the heart of the Quality & Regulatory Affairs function, driving improvements, solving problems, and making sure that Medical Device products meet the highest standards from concept to customer.

Your job as Quality Engineer:

Support product validation/verification activities and ensure outputs shape inspection/test plans.
Maintain and update Technical Files in line with regulatory standards.
Drive improvements in our Quality Management System and internal processes.
Lead root cause analysis and corrective actions during development and production.
Manage change controls, making sure documentation stays compliant.
Support audits (internal and supplier) and follow up on actions.
Promote a culture of quality across the business.
Support the Quality Manager with additional quality-related tasks.

Your experience:

Solid QA experience with a knowledge of ISO 9001, ISO 13485, MDD/MDR, ISO 14971, CFR Part 820
Confident communicator, both internally and with suppliers/customers.
Skilled in quality tools (FMEA, RCA, CAPA, 8D, 5 Whys, MSA, APQP, Minitab/statistical analysis).
Excellent organisational and written skills with the ability to manage your workload.

What's in it for you?

The opportunity to work in a state-of-the-art facility with a team that is not only passionate about the quality of the products but also the needs of the end user. This company have gone from strength to strength and has a reputation built on excellence.

If you have a full right to work in the UK and meet the criteria above, then please get in touch