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Quality assurance specialist - medical devices

Chelmsford
beBee Careers
Quality assurance specialist
Posted: 16h ago
Offer description

Quality Systems Engineer Role

We are seeking a highly motivated Quality Systems Engineer to join our team. In this role, you will play a key part in helping integrate the newly acquired business's Quality Management System (QMS) into the existing framework.

Key Responsibilities:

* Supporting QMS integration projects alongside experienced engineers.
* Helping standardise procedures and close compliance gaps.
* Assisting with the transition to a digital QMS (eQMS) platform.
* Managing key documents like SOPs and forms.
* Getting involved with non-conformance reports (NCRs), internal audits, CAPAs, and supplier assessments.
* Driving continuous improvements and process optimisation projects.
* Learning how to prepare for external audits and regulatory inspections.

Requirements:

* A degree in Engineering (Biomedical, Mechanical, or similar).
* University project or internship experience in medical devices, quality, or product development.
* A keen eye for detail and strong organisational skills.
* A willingness to learn about ISO standards, medical device regulations, and QMS best practices.
* Great communication and teamwork skills.

This is an excellent opportunity to build a career in Quality & Regulatory Affairs. You will be mentored by a highly experienced team and get hands-on with real projects from day one.

This role offers a unique chance to gain valuable experience in quality systems, regulatory affairs, and process improvement. If you are a motivated individual with a passion for quality and excellence, we encourage you to apply.

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