Quality Assurance Engineer - Med Device

JR United Kingdom; Southampton; On-site; GBP 30,000 - 45,000; Full time

Job summary

An exciting opportunity for a Quality Assurance Engineer at a leading medical device company in Southampton. In this role, you will ensure products meet legal and customer standards while managing quality systems. Ideal candidates will have a relevant scientific or engineering degree and proven experience in quality assurance practices.

Qualifications

• Proven industry experience in Quality Systems and operational implementation.
• Working knowledge and practical experience with ISO 13485, CAPA, GDP, and GMP.

Responsibilities

• Support development of the site Quality Management System (QMS).
• Conduct internal quality audits and prepare audit reports.
• Provide guidance on non-conformances and support manufacturing operations.

Skills

Quality Assurance

Quality Systems

ISO 13485

CAPA

GDP

GMP

Regulatory Compliance

Internal Audits

Supplier Quality

Education

Relevant degree in a scientific or engineering discipline

Job description

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Quality Assurance Engineer - Med Device, southampton

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Client:

Hyper Recruitment Solutions

Location:

southampton, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

1

Posted:

06.06.2025

Expiry Date:

21.07.2025

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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:

Your duties as the Quality Assurance Engineer will be varied; however, the key duties and responsibilities are as follows:

1. Support the development of the site Quality Management System (QMS) to meet business requirements.

2. Conduct internal quality audits and prepare audit reports.

3. Support preparation for customer, regulatory, and notified body audits.

4. Provide guidance on non-conformances and support day-to-day manufacturing operations.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Quality Assurance Engineer, we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or engineering discipline.

2. Proven industry experience in Quality Systems and their operational implementation.

3. 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.