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.
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