Quality Assurance Engineer - Med Device

JR United Kingdom; Dartford; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading medical device company in Dartford is seeking a Quality Assurance Engineer. The ideal candidate will ensure products meet regulatory standards and customer expectations, with responsibilities in QMS development and conducting internal audits. Relevant industry experience and a degree in a scientific or engineering field are essential.

Qualifications

• Degree in science or engineering required.
• Experience in Quality Systems and operational implementation.
• Knowledge of ISO standards, CAPA, GDP, and GMP.

Responsibilities

• Support development of site Quality Management System.
• Conduct internal quality audits and prepare audit reports.
• Guide on non-conformances and daily manufacturing operations.

Skills

Quality Management System

Regulatory Compliance

Internal Audits

Education

Relevant degree in a scientific or engineering discipline

Tools

ISO 13485

CAPA

GDP

GMP

Job description

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Quality Assurance Engineer - Med Device, Dartford

Client: Hyper Recruitment Solutions

Location: Dartford, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 1

Posted: 06.06.2025

Expiry Date: 21.07.2025

Job Description:

ROLE OVERVIEW

We are currently looking for a Quality Assurance Engineer to join a leading medical device company based in the SEERS Medical area. As the Quality Assurance Engineer, you will be responsible for ensuring that products and services are fit for purpose, legally compliant, and meet customer expectations.

KEY DUTIES AND RESPONSIBILITIES:

• Support the development of the site Quality Management System (QMS) to meet business requirements.
• Conduct internal quality audits and prepare audit reports.
• Support preparation for customer, regulatory, and notified body audits.
• Provide guidance on non-conformances and support day-to-day manufacturing operations.

ROLE REQUIREMENTS:

• Relevant degree in a scientific or engineering discipline.
• Proven industry experience in Quality Systems and their operational implementation.
• A working knowledge and practical experience with ISO 13485, CAPA requirements, GDP, and GMP.

Key Words: Quality Assurance Engineer, Quality Systems, ISO 13485, CAPA, GDP, GMP, Quality Management System, Medical Devices, Regulatory Compliance, Internal Audits, Supplier Quality

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.