Quality Engineer

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.